Insertion device systems and methods

ABSTRACT

An actuation device includes a lancing device held by and moveable relative to a distal end portion of a housing. A drive member is supported by the housing and arranged to engage the lancing device to move the lancing device in the first direction from a retracted position to an extended position upon movement of the drive member in a first direction. A piercing member of the lancing device is arranged to extend from the distal end portion of the housing by a first distance when the lancing device is moved to the extended position, the first distance being adjustable by adjusting the retracted position of the lancing device relative to the distal end portion of the housing.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.15/908,736, filed Feb. 28, 2018, which is a Divisional of U.S. patentapplication Ser. No. 14/594,014, filed Jan. 9, 2015, U.S. Pat. No.9,943,332, granted Apr. 17, 2018, which is a Divisional of U.S. patentapplication Ser. No. 13/015,051, filed Jan. 27, 2011, U.S. Pat. No.8,932,256, granted Jan. 13, 2015, which is a Continuation-In-Part ofU.S. patent application Ser. No. 12/553,038, filed Sep. 2, 2009, U.S.Pat. No. 8,900,190, granted Dec. 2, 2014, each of which are incorporatedherein by reference in its entirety.

BACKGROUND 1. Field of the Invention

Embodiments of the present invention generally relate to insertiondevice systems and methods, and, in specific embodiments, to insertiondevice systems and methods for insertion into a patient.

2. Related Art

According to modern medical techniques, certain chronic diseases may betreated by delivering a medication or other substance to the body of apatient. For example, diabetes is a chronic disease that is commonlytreated by delivering defined amounts of insulin to a patient atappropriate times. Traditionally, manually operated syringes and insulinpens have been employed for delivering insulin to a patient. Morerecently, modern systems have been designed to include programmablepumps for delivering controlled amounts of medication to a patient.

Pump type delivery devices have been configured in external devices,which connect to a patient, and have been configured in implantabledevices, which are implanted inside of the body of a patient. Externalpump type delivery devices include devices designed for use in astationary location, such as a hospital, a clinic, or the like, andfurther include devices configured for ambulatory or portable use, suchas devices designed to be carried by a patient, or the like. Externalpump-type delivery devices may contain reservoirs of fluidic media, suchas, but is not limited to, insulin.

External pump-type delivery devices may be connected in fluid flowcommunication to a patient or user-patient, for example, throughsuitable hollow tubing. The hollow tubing may be connected to a hollowneedle that is designed to pierce the skin of the patient and to deliverfluidic media there through. Alternatively, the hollow tubing may beconnected directly to the patient as through a cannula, or the like.

Examples of some external pump type delivery devices are described inU.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled“Infusion Device And Method With Disposable Portion” and Published PCTApplication WO 01/70307 (PCT/US01/09139) titled “Exchangeable ElectronicCards For Infusion Devices” (each of which is owned by the assignee ofthe present invention), Published PCT Application WO 04/030716(PCT/US2003/028769) titled “Components And Methods For Patient InfusionDevice,” Published PCT Application WO 04/030717 (PCT/US2003/029019)titled “Dispenser Components And Methods For Infusion Device,” U.S.Patent Application Publication No. 2005/0065760 titled “Method ForAdvising Patients Concerning Doses Of Insulin,” and U.S. Pat. No.6,589,229 titled “Wearable Self-Contained Drug Infusion Device,” each ofwhich is incorporated herein by reference in its entirety.

External pump-type delivery devices may be connected in fluid-flowcommunication to a patient-user, for example, through suitable hollowtubing. The hollow tubing may be connected to a hollow needle that isdesigned to pierce the patient-user's skin and deliver an infusionmedium to the patient-user. Alternatively, the hollow tubing may beconnected directly to the patient-user as or through a cannula or set ofmicro-needles.

In contexts in which the hollow tubing is connected to the patient-userthrough a hollow needle that pierces skin of the user-patient, a manualinsertion of the needle into the patient-user can be somewhat traumaticto the user-patient. Accordingly, insertion mechanisms have been made toassist the insertion of a needle into the user-patient, whereby a needleis forced by a spring to move quickly from a retracted position into anextended position. As the needle is moved into the extended position,the needle is quickly forced through the skin of the user-patient in asingle, relatively abrupt motion that can be less traumatic to certainuser-patients as compared to a slower, manual insertion of a needle.While a quick thrust of the needle into the skin of the user-patient maybe less traumatic to some user-patients than a manual insertion, it isbelieved that, in some contexts, some user-patients may feel less traumaif the needle is moved a very slow, steady pace.

Examples of insertion mechanisms that may be used with and may be builtinto a delivery device are described in: U.S. patent application Ser.No. 11/645,435, filed Dec. 26, 2006, titled “Infusion Medium Deliverysystem, Device And Method With Needle Inserter And Needle InserterDevice And Method,”; and U.S. patent application Ser. No. 11/211,095,filed Aug. 23, 2005, titled “Infusion Device And Method With DisposablePortion” (each of which is assigned to the assignee of the presentinvention), each of which is incorporated herein by reference in itsentirety. Other examples of insertion tools are described in U.S. PatentApplication Publication No. 2002/0022855, titled “Insertion Device ForAn Insertion Set And Method Of Using The Same” (assigned to the assigneeof the present invention), which is incorporated herein by reference inits entirety. Other examples of needle/cannula insertion tools that maybe used (or modified for use) to insert a needle and/or cannula, aredescribed in, for example U.S. patent application Ser. No. 10/389,132filed Mar. 14, 2003, and entitled “Auto Insertion Device For SilhouetteOr Similar Products,” and/or U.S. patent application Ser. No. 10/314,653filed Dec. 9, 2002, and entitled “Insertion Device For Insertion Set andMethod of Using the Same,” both of which are incorporated herein byreference in their entirety. Further examples of various insertion toolsare described in, but are not limited to, U.S. patent application Ser.No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; U.S. patent application Ser. No. 11/646,052, filed Dec. 26,2006, “Infusion Medium Delivery System, Device And Method With NeedleInserter And Needle Inserter Device And Method”; U.S. patent applicationSer. No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method,” all of which are herein incorporated by reference intheir entirety.

Pump-type delivery devices can allow accurate doses of insulin to becalculated and delivered automatically to a patient-user at any timeduring the day or night. Furthermore, when used in conjunction withglucose sensors or monitors, insulin pumps may be automaticallycontrolled to provide appropriate doses of infusion medium atappropriate times of need, based on sensed or monitored levels of bloodglucose.

Pump-type delivery devices have become an important aspect of modernmedical treatments of various types of medical conditions, such asdiabetes. As pump technologies improve and as doctors and patient-usersbecome more familiar with such devices, the popularity of externalmedical infusion pump treatment increases and is expected to increasesubstantially over the next decade.

SUMMARY OF THE DISCLOSURE

An insertion system in accordance with an embodiment of the presentinvention may include, but is not limited to, a base, a first devicehousing, and a second device housing. The base may be adapted to becarried by a patient. The first device housing may be configured to beoperatively engaged with and disengaged from the base. The first devicehousing may include, but is not limited to a first carrier body. Thefirst carrier body may be arranged for movement within at least aportion of the first device housing at least between a retractedposition and an advanced position. The first carrier body may be forsupporting a piercing member in a position orientated for insertionthrough skin of the patient upon movement of the first carrier body fromthe retracted position to the advanced position.

The second device housing may be configured to be operatively engagedwith and disengaged from the first device housing. The second devicehousing may include, but is not limited to, a second carrier body and adrive mechanism. The second carrier body may be arranged for movementwithin at least a portion of the second device housing at least betweena retracted position and an advanced position. The second carrier bodymay be operatively engageable with the first carrier body. The drivemechanism may be arranged within the second device housing for providinga rotational force to cause the first carrier body to move from theretracted position toward the advanced position to insert at least aportion of the piercing member through skin of the patient.

In various embodiments, the drive mechanism may comprise a torsionspring member. In various embodiments, the insertion system may includea cam assembly. The cam assembly may be operatively connected with thedrive mechanism. The cam assembly may be rotatable at least between afirst orientation and a second orientation. The cam assembly may beconfigured to move the second carrier body toward the advanced positionas the cam assembly rotates from the second orientation to the firstorientation. The cam assembly may be configured to move the secondcarrier body toward the retracted position as the cam assembly rotatesfrom the first orientation to the second orientation.

In some embodiments, the cam assembly may have a groove. The secondcarrier body may have a protrusion arranged for movement along thegroove of the cam assembly. The cam assembly may be configured to guidethe protrusion along the groove of the cam assembly as the cam assemblyrotates between the second orientation and the first orientation to movethe second carrier body between the retracted position and the advancedposition.

In further embodiments, the cam assembly may be configured to guide theprotrusion along the groove of the cam assembly as the cam assemblyrotates between the first orientation and the second orientation to movethe second carrier body between the advanced position and the retractedposition.

In further embodiments, the cam assembly may be configured to guide theprotrusion along the groove of the cam assembly as the cam assemblyrotates between the second orientation and the first orientation to movethe second carrier body between the retracted position and the advancedposition. In some embodiments, the drive mechanism may have a firstsetting and a second setting, the drive mechanism biased toward thefirst setting in a case where the drive mechanism is in the secondsetting.

In further embodiments, the drive mechanism may be configured to rotatethe cam assembly to the first orientation to move the second carrierbody to the advanced position as the drive mechanism is returned to thefirst setting. In further embodiments, the drive mechanism may beconfigured to rotate the cam assembly to the second orientation to movethe second carrier body to the retracted position as the drive mechanismis set to the second setting.

In further embodiments, the insertion system may further include anadjustment member. The adjustment member may be for setting the drivemechanism to the second setting. In yet further embodiments, theadjustment member may be configured to rotate the cam assembly to thesecond orientation. The cam assembly may be operatively connected to thedrive mechanism such that rotation of the cam assembly to the secondorientation sets the drive mechanism to the second setting.

In some embodiments, the insertion system may further include a lockingmechanism. The locking mechanism may be adapted to operatively engageand disengage from the cam assembly. The locking mechanism may beconfigured to substantially prevent rotation of the cam assembly in acase where the locking mechanism is engaged with the cam assembly.

In further embodiments, the locking mechanism may comprise a triggermember. At least one of the trigger member and the cam assembly may havea tab for engaging and disengaging from an aperture in the other of theat least one of the trigger and the cam assembly. The locking mechanismmay be configured to substantially prevent rotation of the cam assemblyin a case where the tab is engaged with the aperture.

In various embodiments, the drive mechanism may be arranged within thesecond device housing to move the second carrier body from the retractedposition toward the advanced position to move the first carrier bodyfrom the retracted position toward the advanced positioned to insert atleast a portion of the piercing member through skin of the patient. Invarious embodiments, the first carrier body may be configured tooperatively engage the base when the first carrier body is moved to theadvanced position. In various embodiments, the first carrier body maycomprise a plunger configured to support the piercing member, and toinsert the piercing member in the skin of the user-patient upon movementof the first carrier body from the retracted position to the advancedposition.

In various embodiments, a distance traveled by the first carrier bodyrelative to the first device housing from the retracted position to theadvanced position may be equal to at least a distance traveled by thesecond carrier body relative to the second device housing from theretracted position to the advanced position. In various embodiments, adistance traveled by the first carrier body relative to the first devicehousing from the retracted position to the advanced position may beequal to at least a distance required to insert the piercing member intothe skin of the patient.

In various embodiments, the first carrier body may comprise a plungerand a collar body operatively connected to the plunger. The piercingmember may be supported by at least one of the plunger and the collarbody in a position orientated for insertion through the skin of thepatient upon movement of the first carrier body from the retractedposition to the advanced position.

In some embodiments, the piercing member may comprise a cannulasupported by the collar body and a needle supported by the plunger. Theneedle may be disposed at least partially through the cannula. Thecannula and the needle may be supported in a position orientated forinsertion through the skin of the patient upon movement of the firstcarrier body from the retracted position to the advanced position.

In further embodiments, the plunger and the needle may be removable fromthe collar body. The cannula and the collar body may be adapted forreuse with another collar body and cannula. In further embodiments, thecollar body may have a fluid channel in fluid communication with ahollow interior of the cannula. The fluid channel may be for operativelyconnecting to a reservoir for containing fluidic media when the firstcarrier body is in the advanced position to allow fluidic medic to flowfrom the reservoir to the hollow interior of the cannula.

In various embodiments, the piercing member may comprise a needle. Invarious embodiments, the second carrier body may be configured tooperatively connect with at least two different types of piercingmembers. The second carrier body may be configured to insert at least aportion of a selected one of the at least two different types ofpiercing members in a case where the selected one of the at least twodifferent types of piercing members is operatively connected to thesecond carrier body and the second carrier body is moved to the advancedposition.

In some embodiments, the second carrier body may be configured to beremovable from the selected one of the at least two different types ofpiercing members and adapted for reuse with another one of the at leasttwo different types of piercing members. In some embodiments, theinsertion system may be removable from the selected one of the at leasttwo different types of piercing members. In further embodiments, theinsertion system may be completely removable from the selected one ofthe at least two different types of piercing members.

In some embodiments, the piercing member may be supported by the firstcarrier body is one of the at least two different types of piercingmembers. In some embodiments, the selected one of the at least twodifferent types of piercing members may be an insertion needle of aninsertion set.

In some embodiments, the selected one of the at least two differenttypes of piercing members may be a lancet for obtaining a fluid samplefrom the patient. In further embodiments, the insertion system mayfurther include a guard. The guard may be configured to be removablyattachable to the second device housing. The guard may have an aperturefor allowing the lancet to extend through in a case where the lancet isoperatively connected to the second carrier body and the second carrierbody is moved to the advanced position.

In some embodiments, a distance traveled by the first carrier bodyrelative to the first device housing from the retracted position to theadvanced position may be equal to at least a distance required to insertthe selected one of the at least two different types of piercing membersin the skin of the patient that is at least equal to an implantablelength of the selected one of the at least two different types ofpiercing members.

In various embodiments, at least one of the first device housing and thesecond device housing may have a magnet, and the other of the at leastone of the first device housing and the second device housing may havean attractive element for interacting with the magnet to connect thefirst device housing and the second device housing.

In some embodiments, at least one of the first carrier body and thesecond carrier body may have a magnet, and the other of the at least oneof the first carrier body and the second carrier body may have anattractive element for interacting with the magnet to connect the firstcarrier body and the second carrier body. In some embodiments, theattractive element may comprise one of a ferrous material and a magnet.

In various embodiments, the first device housing may have a section forsupporting a portion of the first carrier body and for preventing thefirst carrier body from moving to the advanced position, the section maybe moveable relative to the first carrier body. The second devicehousing may be configured to cause movement of the section of the firstdevice housing to provide sufficient clearance to allow the firstcarrier body to move to the advanced position in a case where the firstcarrier body is moved by the second carrier body.

In some embodiments, the second device housing may have a portion foroperatively engaging the section of the first device housing to causemovement of the section of the first device housing in a case where thesecond device housing is operatively connected with the first devicehousing and the second device housing is rotated relative to the firstdevice housing.

A method of manufacturing an insertion system may include, but is notlimited to, any one of or combination of: (i) adapting a base to becarried by a patient; configuring a first device housing to beoperatively engaged with and disengaged from the base, configuring thefirst device housing comprising: arranging a first carrier body formovement within at least a portion of the first device housing at leastbetween a retracted position and an advanced position, the first carrierbody for supporting a piercing member in a position orientated forinsertion through skin of the patient upon movement of the first carrierbody from the retracted position to the advanced position; and (iii)configuring a second device housing to be operatively engaged with anddisengaged from the first device housing, configuring the second devicehousing comprising: (a) arranging a second carrier body for movementwithin at least a portion of the second device housing at least betweena retracted position and an advanced position, the second carrier bodyoperatively engageable with the first carrier body; and (b) arranging adrive mechanism within the second device housing for providing arotational force to cause the first carrier body to move from theretracted position toward the advanced position to insert at least aportion of the piercing member through skin of the patient.

An insertion system, the insertion system may include a device housing.The device housing may be configured to be operatively engaged with anddisengaged from a base adapted to be carried by a patient. The devicehousing may be engageable with an actuation device. The device housingmay include, but is not limited to, a carrier body. The carrier body maybe arranged for movement within at least a portion of the device housingat least between a retracted position and an advanced position. Thecarrier body may be for supporting a piercing member in a positionorientated for insertion through skin of the patient upon movement ofthe carrier body from the retracted position to the advanced position.The carrier body may be operatively engageable with a moveable carrierbody of the actuation device so that the carrier body of the devicehousing moved by the carrier body of the actuation device at leastbetween the retracted position and the advanced position.

The device housing may have a section for supporting a portion of thecarrier body of the device housing and for preventing the carrier bodyof the device housing from moving to the advanced position. The sectionmay be moveable relative to the carrier body of the device housing toprovide sufficient clearance to allow the carrier body of the devicehousing to move to the advanced position in a case where the carrierbody of the device housing is moved by the carrier body of the actuationdevice.

In various embodiments, the system may further include the actuationdevice. The actuation device may be configured to be operatively engagedwith and disengaged from the device housing. The carrier body of theactuation device may be arranged for movement within at least a portionof the actuation device at least between a retracted position and anadvanced position. The carrier body of the actuation device may beoperatively engageable with the carrier body of the device housing.

In some embodiments, the system may further include a drive mechanism.The drive mechanism may be arranged within the actuation device to movethe carrier body of the device housing from the retracted positiontoward the advanced position to insert at least a portion of thepiercing member through skin of the patient. In further embodiments, thedrive mechanism may be configured to provide a rotational force to causethe carrier body of the device housing to move from the retractedposition toward the advanced position to insert at least a portion ofthe piercing member through skin of the patient.

In some embodiments, the actuation device may be configured to causemovement of the section of the device housing to provide sufficientclearance to allow the carrier body of the device housing to move to theadvanced position in a case where the carrier body of the device housingis moved by the carrier body of the actuation device.

In various embodiments, at least one of the device housing and theactuation device may have a magnet, and the other of the at least one ofthe device housing and the actuation device may have an attractiveelement for interacting with the magnet to connect the device housingand the actuation device.

In some embodiments, at least one of the carrier body of the devicehousing and the carrier body of the actuation device may have a magnet,and the other of the at least one of the carrier body of the devicehousing and the carrier body of the actuation device may have anattractive element for interacting with the magnet to connect thecarrier body of the device housing and the carrier body of the actuationdevice. In some embodiments, the attractive element may comprise one ofa ferrous material and a magnet.

In various embodiments, the device housing may further include anengagement member. The engagement member may be engageable with anddisengageable from the base to operatively engage and disengage thedevice housing and the base. At least one of the base and the engagementmember may be configured such that the engagement member is preventedfrom engaging the base in a case where the engagement member has beendisengaged from the base unless a second force having a magnitude equalto or greater than the first force is applied to the engagement member.

In various embodiments, the piercing member may comprise a needle. Invarious embodiments, the carrier body of the device housing may comprisea plunger configured to support the piercing member, and to insert thepiercing member in the skin of the user-patient upon movement of thecarrier body of the device housing from the retracted position to theadvanced position. In various embodiments, a distance traveled by thecarrier body of the device housing relative to the device housing fromthe retracted position to the advanced position may be equal to at leasta distance required to insert the piercing member into the skin of thepatient.

In various embodiments, the carrier body of the device housing maycomprise a plunger and a collar body operatively connected to theplunger. The piercing member may be supported by at least one of theplunger and the collar body in a position orientated for insertionthrough the skin of the patient upon movement of the carrier body of thedevice housing from the retracted position to the advanced position.

In some embodiments, the piercing member may comprise a cannulasupported by the collar body and a needle supported by the plunger. Theneedle may be disposed at least partially through the cannula. Thecannula and the needle may be supported in a position orientated forinsertion through the skin of the patient upon movement of the carrierbody of the device housing from the retracted position to the advancedposition.

In further embodiments, the plunger and the needle may be removable fromthe collar body. The cannula and the collar body may be adapted forreuse with another collar body and cannula. In further embodiments, thecollar body may have a fluid channel in fluid communication with ahollow interior of the cannula; the fluid channel may be for operativelyconnecting to a reservoir for containing fluidic media when the carrierbody of the device housing is in the advanced position to allow fluidicmedic to flow from the reservoir to the hollow interior of the cannula.

A method of manufacturing an insertion system may include, but is notlimited to, any one of or combination of: (i) configuring a devicehousing configured to be operatively engaged with and disengaged from abase adapted to be carried by a patient, the device housing engageablewith an actuation device, configuring the device housing comprising:arranging a carrier body for movement within at least a portion of thedevice housing at least between a retracted position and an advancedposition, the carrier body for supporting a piercing member in aposition orientated for insertion through skin of the patient uponmovement of the carrier body from the retracted position to the advancedposition, the carrier body operatively engageable with a moveablecarrier body of the actuation device so that the carrier body of thedevice housing moved by the carrier body of the actuation device atleast between the retracted position and the advanced position; and (ii)arranging a section of the device housing to support a portion of thecarrier body of the device housing and for preventing the carrier bodyof the device housing from moving to the advanced position, the sectionmoveable relative to the carrier body of the device housing to providesufficient clearance to allow the carrier body of the device housing tomove to the advanced position in a case where the carrier body of thedevice housing is moved by the carrier body of the actuation device.

An insertion system may include, but is not limited to, a base, a devicehousing, and an engagement member. The base may be adapted to be carriedby a patient. The device housing may be configured to be operativelyengaged with and disengaged from the base. The device housing may beengageable with an actuation device. The device housing may include, butis not limited to, a carrier body and an engagement member. The carrierbody may be arranged for movement within at least a portion of thedevice housing at least between a retracted position and an advancedposition, the carrier body for supporting a piercing member in aposition orientated for insertion through skin of the patient uponmovement of the carrier body from the retracted position to the advancedposition. The carrier body may be operatively engageable with a moveablecarrier body of the actuation device so that the carrier body of thedevice housing moved by the carrier body of the actuation device atleast between the retracted position and the advanced position.

The engagement member may be engageable with and disengageable from thebase to operatively engage and disengage the device housing and thebase. The engagement member may be configured to engage the base in acase where a first force of at least a particular magnitude is appliedto the engagement member. At least one of the base and the engagementmember may be configured such that the engagement member is preventedfrom engaging the base in a case where the engagement member has beendisengaged from the base unless a second force having a magnitude equalto or greater than the first force is applied to the engagement member.

In various embodiments, at least one of the base and the engagementmember may have a reengagement prevention member for preventing theengagement member from engaging the base in a case where the engagementmember has been disengaged from the based unless the second force isapplied to the engagement member. In some embodiments, the reengagementprevention member may comprise an abutment of the engagement member. Theabutment may be for preventing the engagement member from engaging thebase in a case where the engagement member has been disengaged from thebased unless the second force is applied to the engagement member.

In some embodiments, the engagement member may be engageable with anddisengageable from an aperture of the base to operatively engage anddisengage the device housing and the base. The at least one of the baseand the engagement member may have a reengagement prevention membercomprises an abutment of the engagement member. The abutment may be forpreventing the engagement member from engaging the base in a case wherethe engagement member has been disengaged from the based.

In various embodiments, the engagement member may be engageable with anddisengageable from an aperture of the base to operatively engage anddisengage the device housing and the base. In various embodiments, theengagement member may be a lever. In various embodiments, the piercingmember may comprise a needle.

In various embodiments, the carrier body of the device housing maycomprise a plunger configured to support the piercing member, and toinsert the piercing member in the skin of the user-patient upon movementof the carrier body of the device housing from the retracted position tothe advanced position. In various embodiments, a distance traveled bythe carrier body of the device housing relative to the device housingfrom the retracted position to the advanced position may be equal to atleast a distance required to insert the piercing member into the skin ofthe patient.

In various embodiments, the carrier body of the device housing maycomprise a plunger and a collar body operatively connected to theplunger. The piercing member may be supported by at least one of theplunger and the collar body in a position orientated for insertionthrough the skin of the patient upon movement of the carrier body of thedevice housing from the retracted position to the advanced position.

In some embodiments, the piercing member may comprise a cannulasupported by the collar body and a needle supported by the plunger. Theneedle may be disposed at least partially through the cannula. Thecannula and the needle may be supported in a position orientated forinsertion through the skin of the patient upon movement of the carrierbody of the device housing from the retracted position to the advancedposition.

In further embodiments, the plunger and the needle may be removable fromthe collar body. The cannula and the collar body may be adapted forreuse with another collar body and cannula. In further embodiments, thecollar body may have a fluid channel in fluid communication with ahollow interior of the cannula. The fluid channel may be for operativelyconnecting to a reservoir for containing fluidic media when the carrierbody of the device housing is in the advanced position to allow fluidicmedic to flow from the reservoir to the hollow interior of the cannula.

A method of manufacturing an insertion system may include, but is notlimited to, any one of or combination of: (i) adapting a base to becarried by a patient; (ii) configuring a device housing to beoperatively engaged with and disengaged from the base, the devicehousing engageable with an actuation device, configuring the devicehousing comprising: arranging a carrier body for movement within atleast a portion of the device housing at least between a retractedposition and an advanced position, the carrier body for supporting apiercing member in a position orientated for insertion through skin ofthe patient upon movement of the carrier body from the retractedposition to the advanced position, the carrier body operativelyengageable with a moveable carrier body of the actuation device so thatthe carrier body of the device housing moved by the carrier body of theactuation device at least between the retracted position and theadvanced position; (iii) providing an engagement member engageable withand disengageable from the base to operatively engage and disengage thedevice housing and the base, the engagement member configured to engagethe base in a case where a first force of at least a particularmagnitude is applied to the engagement member; and (iv) configuring atleast one of the base and the engagement member such that the engagementmember is prevented from engaging the base in a case where theengagement member has been disengaged from the base unless a secondforce having a magnitude equal to or greater than the first force isapplied to the engagement member.

An insertion detection system may include, but is not limited to, abase, a housing, a pair of interactive elements, and circuitry. The basemay be adapted to be carried by a patient. The housing may be attachedto the base. The housing may have a fluid connector arranged formovement relative to the base. The pair of interactive elements mayinclude a first interactive element supported on the base and a secondinteractive element supported on the housing at a location to beinteractable with the first interactive element when the fluid connectoris moved to a predetermined position. The circuitry may be configured todetect an interaction between the first interactive element and thesecond interactive element when the fluid connector is in thepredetermined position. The circuitry may be configured to provide asignal or a change in state in response to detecting the interactionbetween the first interactive element and the second interactiveelement.

In some embodiments, the housing may include a carrier body arranged formovement within at least a portion of the housing at least between aretracted position and an advanced position. The carrier body may be forsupporting the fluid connector in a position orientated for insertionthrough skin of the patient upon movement of the carrier body from theretracted position to the advanced position. The second interactiveelement may be supported on the carrier body.

In further embodiments, the housing may be configured to be operativelyengaged to an actuation device for selectively moving the carrier bodyfrom the retracted position toward the advanced position to insert atleast a portion of the fluid connector through skin of the patient.

In further embodiments, the fluid connector may be in the predeterminedposition when the carrier body is in the advanced position so that thefluid connector is inserted through the skin of the patient.

In yet further embodiments, the fluid connector may be in thepredetermined position when the carrier body is in the advanced positionso that the fluid connector is inserted in the skin of the patient adefined depth.

In further embodiments, the fluid connector may be in the predeterminedposition when the carrier body is in the advanced position so that thefirst interactive element and the second interactive element aresufficiently proximate to each other.

In some embodiments, the fluid connector may be in the predeterminedposition when the first interactive element and the second interactiveelement are sufficiently proximate to each other.

In further embodiments, the first interactive element and the secondinteractive element may be sufficiently proximate to each other in acase where the first interactive element and the second interactiveelement contact each other.

In some embodiments, the fluid connector may be in the predeterminedposition when the fluid connector is in fluid communication with a fluidpath of the base.

In some embodiments, the fluid connector may comprise at least one of acannula and a needle.

In some embodiments, the system may further include a user-perceptibleindicator operatively connected to the circuitry. The user-perceptibleindicator may be for providing a user-perceptible indication in responseto the signal or the change in state by the circuitry.

In further embodiments, the user-perceptible indication may comprise atleast one of an audible indication, a visual indication, and a tactileindication.

In some embodiments, the first interactive element and the secondinteractive element may be configured to be electronically interactablewith each other.

In some embodiments, one of the base and the housing may support areservoir having an interior volume for containing fluidic media and aplunger head moveable within the interior volume of the reservoir alongan axial direction of the reservoir. The system may further include adrive device and control electronics. The drive device may be supportedby the other of the base and the housing relative to the one of the baseand the housing supporting the reservoir. The control electronics may beoperatively connected to the circuitry for controlling the drive deviceto drive fluid from the reservoir based upon the signal or the stateprovided by the circuitry.

In further embodiments, the control electronics may be configured toinhibit operation of the drive device unless a signal or a stateprovided by the circuitry corresponds to the signal or the stateprovided by the circuitry when detecting the interaction between thefirst interactive element and the second interactive element.

In further embodiments, the control electronics may be configured tochange from a first power state to a second power state in response todetecting the interaction between the first interactive element and thesecond interactive element.

In further embodiments, the fluid connector may comprise the reservoir.

In some embodiments, the first interactive element may comprise adetectable feature. The second interactive element may comprise a sensorconfigured to sense the detectable feature when the fluid connector ismoved to the predetermined position. The circuitry may be configured toprovide the signal or the change in state in a case where the detectablefeature is detected by the sensor.

In further embodiments, the sensor may comprise at least one magneticsensor. The detectable feature may comprise a magnetic material.

In some embodiments, one of the first interactive element and the secondinteractive element may have a capacitance that is measurable. The otherof the one of the first interactive element and the second interactiveelement may be configured to affect the capacitance when the fluidconnector is in the predetermined position. The circuitry may beconfigured to provide the signal or the change in state when thecapacitance is affected by the other of the one of the first interactiveelement and the second interactive element.

In some embodiments, one of the first interactive element and the secondinteractive element may have an inductance that is measurable. The otherof the one of the first interactive element and the second interactiveelement may be configured to affect the inductance when the fluidconnector is in the predetermined position. The circuitry may beconfigured to provide the signal or the change in state when theinductance is affected by the other of the one of the first interactiveelement and the second interactive element.

In some embodiments, the housing may be configured to be operativelyengaged with and disengaged from the base.

In some embodiments, the housing may be integral with the base.

In some embodiments, one of the first interactive element and the secondinteractive element may include data or information. The other of theone of the first interactive element and the second interactive elementis configured to access the data or information of the one of the firstinteractive element and the second interactive element when the firstelement and the second element interact.

In further embodiments, the circuitry may be configured to provide asignal or a change in state based on the data or information accessed bythe other of the one of the first interactive element and the secondinteractive element.

In some embodiments, the fluid connector may include data orinformation. One of the first interactive element and the secondinteractive element may be configured to access the data or informationwhen the first element and the second element interact.

A method of manufacturing an insertion detection system may include, butis not limited to, any one or combination of: (i) adapting a base to becarried by a patient; (ii) arranging a housing on the base, the housinghaving a fluid connector arranged for movement relative to the base;(iii) providing a pair of interactive elements including a firstinteractive element supported on the base and a second interactiveelement supported on the housing at a location to be interactable withthe first interactive element when the fluid connector is moved to apredetermined position; and (iv) configuring circuitry to detect aninteraction between the first interactive element and the secondinteractive element when the fluid connector is in the predeterminedposition, the circuitry configured to provide a signal or a change instate in response to detecting the interaction between the firstinteractive element and the second interactive element.

An insertion detection system may include, but is not limited to, abase, a housing, a carrier body, a pair of interactive elements, andcircuitry. The base may be adapted to be carried by a patient. Thehousing may be attached to the base. The carrier body may be arrangedfor movement within at least a portion of the housing at least between aretracted position and an advanced position. The carrier body may be forsupporting a piercing member in a position orientated for insertionthrough skin of the patient upon movement of the carrier body from theretracted position to the advanced position. The pair of interactiveelements may include a first interactive element supported on the baseand a second interactive element supported on the housing at a locationto be interactable with the first interactive element when the fluidconnector is positioned in a predetermined position. The circuitry maybe configured to detect an interaction between the first interactiveelement and the second interactive element when the piercing member ispositioned in the predetermined position. The circuitry may beconfigured to provide a signal or a change in state in response todetecting an interaction between the first interactive element and thesecond interactive element.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a generalized representation of a system inaccordance with an embodiment of the present invention;

FIG. 2 illustrates an example of a system in accordance with anembodiment of the present invention;

FIG. 3 illustrates an example of a delivery device in accordance with anembodiment of the present invention;

FIG. 4 illustrates a delivery device in accordance with an embodiment ofthe present invention;

FIG. 5A illustrates a durable portion of a delivery device in accordancewith an embodiment of the present invention;

FIG. 5B illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 5C illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6A illustrates a disposable portion of a delivery device inaccordance with an embodiment of the present invention;

FIG. 6B illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6C illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 7 illustrates portions of a medical device in accordance with anembodiment of the present invention;

FIG. 8 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 9 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 10 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 11 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 12 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 13 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 14 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 15 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 16 illustrates cross-section of a needle-inserting device inaccordance with an embodiment of the present invention;

FIG. 17 illustrates a medial device in accordance with an embodiment ofthe present invention;

FIG. 18 illustrates a medial device in accordance with an embodiment ofthe present invention;

FIG. 19 illustrates a medial device in accordance with an embodiment ofthe present invention;

FIG. 20 illustrates a medial device in accordance with an embodiment ofthe present invention;

FIG. 21 illustrates flow chart for using a medial device in accordancewith an embodiment of the present invention;

FIG. 22 illustrates a medial device in accordance with an embodiment ofthe present invention;

FIG. 23 illustrates a medial device in accordance with an embodiment ofthe present invention;

FIG. 24 illustrates flow chart for using a medial device in accordancewith an embodiment of the present invention;

FIG. 25 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 26 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 27 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 28 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 29 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 30 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 31 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 32 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 33 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 34 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 35 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 36 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 37 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 38 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 39 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 40 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 41 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 42 illustrates a portion of a medial device in accordance with anembodiment of the present invention;

FIG. 43 illustrates a portion of a medial device in accordance with anembodiment of the present invention; and

FIG. 44 is a block diagram of a portion of a medical device inaccordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a generalized representation of a system 10 inaccordance with an embodiment of the present invention. The system 10may include a delivery device 12. The system 10 may further include asensing device 14, a command control device (CCD) 16, and a computer 18.In various embodiments, the delivery device 12 and the sensing device 14may be secured at desired locations on the body 5 of a patient oruser-patient 7. The locations at which the delivery device 12 and thesensing device 14 are secured to the body 5 of the user-patient 7 inFIG. 1 are provided only as representative, non-limiting, examples.

The system 10, the delivery device 12, the sensing device 14, the CCD16, and computer 18 may be similar to those described in the followingU.S. patent applications that were assigned to the assignee of thepresent invention, where each of following patent applications isincorporated herein by reference in its entirety: (i) U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, “Infusion DeviceAnd Method With Disposable Portion”; (ii) U.S. patent application Ser.No. 11/515,225, filed Sep. 1, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (iii) U.S.patent application Ser. No. 11/588,875, filed Oct. 27, 2006, “SystemsAnd Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (iv) U.S. patent application Ser. No. 11/588,832, filed Oct.27, 2006, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (v) U.S. patent application Ser. No.11/588,847, filed Oct. 27, 2006, “Infusion Medium Delivery Device AndMethod With Compressible Or Curved Reservoir Or Conduit”; (vi) U.S.patent application Ser. No. 11/589,323, filed Oct. 27, 2006, “InfusionPumps And Methods And Delivery Devices And Methods With Same”; (vii)U.S. patent application Ser. No. 11/602,173, filed Nov. 20, 2006,“Systems And Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (viii) U.S. patent application Ser. No. 11/602,052, filedNov. 20, 2006, “Systems And Methods Allowing For Reservoir Filling AndInfusion Medium Delivery”; (ix) U.S. patent application Ser. No.11/602,428, filed Nov. 20, 2006, “Systems And Methods Allowing ForReservoir Filling And Infusion Medium Delivery”; (x) U.S. patentapplication Ser. No. 11/602,113, filed Nov. 20, 2006, “Systems AndMethods Allowing For Reservoir Filling And Infusion Medium Delivery”;(xi) U.S. patent application Ser. No. 11/604,171, filed Nov. 22, 2006,“Infusion Medium Delivery Device And Method With Drive Device ForDriving Plunger In Reservoir”; (xii) U.S. patent application Ser. No.11/604,172, filed Nov. 22, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (xiii) U.S.patent application Ser. No. 11/606,703, filed Nov. 30, 2006, “InfusionPumps And Methods And Delivery Devices And Methods With Same”; (xiv)U.S. patent application Ser. No. 11/606,836, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;U.S. patent application Ser. No. 11/636,384, filed Dec. 8, 2006,“Infusion Medium Delivery Device And Method With Compressible Or CurvedReservoir Or Conduit”; (xv) U.S. patent application Ser. No. 11/645,993,filed Dec. 26, 2006, “Infusion Medium Delivery Device And Method WithCompressible Or Curved Reservoir Or Conduit”; U.S. patent applicationSer. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xvi) U.S. patent application Ser. No. 11/646,052,filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And MethodWith Needle Inserter And Needle Inserter Device And Method”; (xvii) U.S.patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “InfusionMedium Delivery System, Device And Method With Needle Inserter AndNeedle Inserter Device And Method”; (xviii) U.S. patent application Ser.No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; (xix) U.S. patent application Ser. No. 11/759,725, filed Jun.7, 2007, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (xx) U.S. patent application Ser. No.11/606,837, filed Nov. 30, 2006, “Method And Apparatus For Enhancing TheIntegrity Of An Implantable Sensor Device”; (xxi) U.S. patentapplication Ser. No. 11/702,713, filed Feb. 5, 2007, “Selective PottingFor Controlled Failure And Electronic Devices Employing The Same”;(xxii) U.S. patent application Ser. No. 11/843,601, filed Aug. 22, 2007,“System And Method For Sensor Recalibration”; (xxiii) U.S. patentapplication Ser. No. 11/868,898, filed Oct. 8, 2007, “MultilayerSubstrate”; (xxiv) U.S. patent application Ser. No. 11/964,649, filedDec. 26, 2007, “System And Methods Allowing For Reservoir Air BubbleManagement”; (xxv) U.S. patent application Ser. No. 12/111,751, filedApr. 29, 2008, “Systems And Methods For Reservoir Filling”; (xxvi) U.S.patent application Ser. No. 12/111,815, filed Apr. 29, 2008, “SystemsAnd Methods For Reservoir Air Bubble Management”; (xxvii) U.S. patentapplication Ser. No. 11/924,402, filed Oct. 25, 2007, “Sensor SubstrateAnd Method Of Fabricating Same”; (xxviii) U.S. patent application Ser.No. 11/929,428, filed Oct. 30, 2007, “Telemetry System And Method WithVariable Parameters”; (xxix) U.S. patent application Ser. No.11/965,578, filed Dec. 27, 2007, “Reservoir Pressure EqualizationSystems And Methods”; (xxx) U.S. patent application Ser. No. 12/107,580,filed Apr. 22, 2008, “Automative Filling Systems And Methods”; (xxxi)U.S. patent application Ser. No. 11/964,663, filed Dec. 26, 2007,“Medical Device With Full Options And Selective Enablement/Disablement”;(xxxii) U.S. patent application Ser. No. 10/180,732, filed Jun. 26,2002, “Communication Station And Software For Interfacing With AnInfusion Pump, Analyte Monitor, Analyte Meter, Or The Like”; (xxxiii)U.S. patent application Ser. No. 12/099,738, filed Apr. 8, 2008,“Systems And Methods Allowing For Reservoir Air Bubble Management”;(xxxiv) U.S. patent application Ser. No. 12/027,963, filed Feb. 7, 2008,“Adhesive Patch Systems And Methods”; (xxxv) U.S. patent applicationSer. No. 12/121,647, filed May 15, 2008, “Multi-Lumen Catheter”; (xxxvi)U.S. Patent Provisional Application Ser. No. 61/044,269, filed Apr. 11,2008, “Reservoir Plunger Head Systems And Methods”; (xxxvii) U.S. PatentApplication Ser. No. 61/044,292, filed Apr. 11, 2008, “Reservoir BarrierLayer Systems And Methods”; (xxxviii) U.S. Patent ProvisionalApplication Ser. No. 61/044,322, filed Apr. 11, 2008, “Reservoir SealRetainer Systems And Methods”; (xxxix) U.S. patent application Ser. No.12/179,502, filed Jul. 24, 2008, “Method For Formulating AndImmobilizing A Matrix Protein And A Matrix Protein For Use In A Sensor”;(xl) U.S. patent application Ser. No. 12/336,367, filed Dec. 16, 2008,“Needle Insertions Systems And Methods”; (xli) U.S. patent applicationSer. No. 12/166,210, filed Jul. 1, 2008, “Electronic Device ForControlled Failure”; (xlii) U.S. patent application Ser. No. 12/271,134,filed Nov. 14, 2008, “Multilayer Circuit Devices And ManufacturingMethods Using Electroplated Sacrificial Structures”; (xliii) U.S. patentapplication Ser. No. 12/171,971, filed Jul. 11, 2008, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method”; (xliv) U.S. patent application Ser. No.12/189,077, filed Aug. 8, 2008, “Packaging System”; (xlv) U.S. patentapplication Ser. No. 12/179,536, filed Jul. 24, 2008, “Real TimeSelf-Adjusting Calibration Algorithm”; (xlvii) U.S. patent applicationSer. No. 12/277,186, filed Nov. 24, 2008, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xlviii) U.S. patent application Ser. No.12/211,783, filed Sep. 16, 2008, “Implantable Sensor Method And System”;(xlix) U.S. patent application Ser. No. 12/247,945, filed Oct. 8, 2008,“Infusion Medium Delivery Device And Method With Drive Device ForDriving Plunger In Reservoir”; (l) U.S. patent application Ser. No.12/360,077, filed Jan. 26, 2009, “Reservoir Barrier Layer Systems AndMethods”; (li) U.S. patent application Ser. No. 12/345,362, filed Dec.29, 2008, “Reservoir Seal Retainer Systems And Methods”; (lii) U.S.patent application Ser. No. 12/353,181, filed Jan. 13, 2009, “SystemsAnd Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (liii) U.S. patent application Ser. No. 12/360,813, filedJan. 27, 2009, “Multi-Position Infusion Set Device And Process”; (liv)U.S. Patent Pub. No. US 2007/0142776 (application Ser. No. 10/314,653),filed Dec. 9, 2002, “Insertion Device For An Insertion Set and MethodsOf Using The Same.” In other embodiments, the system 10, delivery device12, sensing device 14, CCD 16, and computer 18 may have other suitableconfigurations.

The delivery device 12 may be configured to deliver fluidic media to thebody 5 of the user-patient 7. In various embodiments, fluidic media mayinclude a liquid, a fluid, a gel, or the like. In some embodiments,fluidic media may include a medicine or a drug for treating a disease ora medical condition. For example, fluidic media may include insulin fortreating diabetes, or may include a drug for treating pain, cancer, apulmonary disorder, HIV, or the like. In some embodiments, fluidic mediamay include a nutritional supplement, a dye, a tracing medium, a salinemedium, a hydration medium, or the like.

The sensing device 14 may include a sensor, a monitor, or the like, forproviding sensor data or monitor data. In various embodiments, thesensing device 14 may be configured to sense a condition of theuser-patient 7. For example, the sensing device 14 may includeelectronics and enzymes reactive to a biological condition, such as ablood glucose level, or the like, of the user-patient 7.

In various embodiments, the sensing device 14 may be secured to the body5 of the user-patient 7 or embedded in the body 5 of the user-patient 7at a location that is remote from the location at which the deliverydevice 12 is secured to the body 5 of the user-patient 7. In variousother embodiments, the sensing device 14 may be incorporated within thedelivery device 12. In other embodiments, the sensing device 14 may beseparate and apart from the delivery device, and may be, for example,part of the CCD 16. In such embodiments, the sensing device 14 may beconfigured to receive a biological sample, analyte, or the like, tomeasure a condition of the user-patient 7.

In further embodiments, the sensing device 14 and/or the delivery device12 may utilize a closed-loop system. Examples of sensing devices and/ordelivery devices utilizing closed-loop systems may be found at, but arenot limited to, the following references: (i) U.S. Pat. No. 6,088,608,entitled “Electrochemical Sensor And Integrity Tests Therefor”; (ii)U.S. Pat. No. 6,119,028, entitled “Implantable Enzyme-Based MonitoringSystems Having Improved Longevity Due To Improved Exterior Surfaces”;(iii) U.S. Pat. No. 6,589,229, entitled “Implantable Enzyme-BasedMonitoring Systems Adapted for Long Term Use”; (iv) U.S. Pat. No.6,740,072, entitled “System And Method For Providing Closed LoopInfusion Formulation Delivery”; (v) U.S. Pat. No. 6,827,702, entitled“Safety Limits For Closed-Loop Infusion Pump Control”; (vi) U.S. Pat.No. 7,323,142, entitled “Sensor Substrate And Method Of FabricatingSame”; (vii) U.S. patent application Ser. No. 09/360,342, filed Jul. 22,1999, entitled “Substrate Sensor”; and (viii) U.S. Provisional PatentApplication Ser. No. 60/318,060, filed Sep. 7, 2001, entitled “SensingApparatus and Process”, all of which are incorporated herein byreference in their entirety.

In such embodiments, the sensing device 14 may be configured to sense acondition of the user-patient 7, such as, but not limited to, bloodglucose level, or the like. The delivery device 12 may be configured todeliver fluidic media in response to the condition sensed by the sensingdevice 14. In turn, the sensing device 14 may continue to sense a newcondition of the user-patient, allowing the delivery device 12 todeliver fluidic media continuously in response to the new conditionsensed by the sensing device 14 indefinitely. In some embodiments, thesensing device 14 and/or the delivery device 12 may be configured toutilize the closed-loop system only for a portion of the day, forexample only when the user-patient is asleep or awake.

Each of the delivery device 12, the sensing device 14, the CCD 16, andthe computer 18 may include transmitter, receiver, or transceiverelectronics that allow for communication with other components of thesystem 10. The sensing device 14 may be configured to transmit sensordata or monitor data to the delivery device 12. The sensing device 14may also be configured to communicate with the CCD 16. The deliverydevice 12 may include electronics and software that are configured toanalyze sensor data and to deliver fluidic media to the body 5 of theuser-patient 7 based on the sensor data and/or preprogrammed deliveryroutines.

The CCD 16 and the computer 18 may include electronics and othercomponents configured to perform processing, delivery routine storage,and to control the delivery device 12. By including control functions inthe CCD 16 and/or the computer 18, the delivery device 12 may be madewith more simplified electronics. However, in some embodiments, thedelivery device 12 may include all control functions, and may operatewithout the CCD 16 and the computer 18. In various embodiments, the CCD16 may be a portable electronic device. In addition, in variousembodiments, the delivery device 12 and/or the sensing device 14 may beconfigured to transmit data to the CCD 16 and/or the computer 18 fordisplay or processing of the data by the CCD 16 and/or the computer 18.

In some embodiments, the sensing device 14 may be integrated into theCCD 16. Such embodiments may allow the user-patient to monitor acondition by providing, for example, a sample of his or her blood to thesensing device 14 to assess his or her condition. In some embodiments,the sensing device 14 and the CCD 16 may be for determining glucoselevels in the blood and/or body fluids of the user-patient without theuse of, or necessity of, a wire or cable connection between the deliverydevice 12 and the sensing device 14 and/or the CCD 16.

In some embodiments, the CCD 16 may be for providing information to theuser-patient that facilitates the user-patient's subsequent use of adrug delivery system. For example, the CCD 16 may provide information tothe user-patient to allow the user-patient to determine the rate or doseof medication to be administered into the body of the user-patient. Inother embodiments, the CCD 16 may provide information to the deliverydevice 12 to control the rate or dose of medication administered intothe body of the user-patient

Examples of the types of communications and/or control capabilities, aswell as device feature sets and/or program options may be found in thefollowing references: (i) U.S. patent application Ser. No. 10/445,477,filed May 27, 2003, entitled “External Infusion Device with RemoteProgramming, Bolus Estimator and/or Vibration Alarm Capabilities”; (ii)U.S. patent application Ser. No. 10/429,385, filed May 5, 2003, entitled“Handheld Personal Data Assistant (PDA) with a Medical Device and Methodof Using the Same”; and (iii) U.S. patent application Ser. No.09/813,660, filed Mar. 21, 2001, entitled “Control Tabs for InfusionDevices and Methods of Using the Same,” all of which are incorporatedherein by reference in their entirety.

FIG. 2 illustrates an example of the system 10 in accordance with anembodiment of the present invention. The system 10 in accordance withthe embodiment illustrated in FIG. 2 includes the delivery device 12 andthe sensing device 14. The delivery device 12 in accordance with anembodiment of the present invention may include a disposable housing 20,a durable housing 30, and a reservoir system 40. The delivery device 12may further include an infusion path 50.

Elements of the delivery device 12 that ordinarily contact the body of auser-patient or that ordinarily contact fluidic media during operationof the delivery device 12 may be considered as a disposable portion ofthe delivery device 12. For example, a disposable portion of thedelivery device 12 may include the disposable housing 20 and thereservoir system 40. The disposable portion of the delivery device 12may be recommended for disposal after a specified number of uses.

On the other hand, elements of the delivery device 12 that do notordinarily contact the body of the user-patient or fluidic media duringoperation of the delivery device 12 may be considered as a durableportion of the delivery device 12. For example, a durable portion of thedelivery device 12 may include the durable housing 30, electronics (notshown in FIG. 2), a drive device having a motor and drive linkage (notshown in FIG. 2), and the like. Elements of the durable housing portionof the delivery device 12 are typically not contaminated from contactwith the user-patient or fluidic media during normal operation of thedelivery device 12 and, thus, may be retained for re-use with replaceddisposable portions of the delivery device 12.

In various embodiments, the disposable housing 20 may support thereservoir system 40 and has a bottom surface (facing downward and intothe page in FIG. 2) configured to secure to the body of theuser-patient. An adhesive may be employed at an interface between thebottom surface of the disposable housing 20 and the skin of theuser-patient to adhere the disposable housing 20 to the skin of theuser-patient. In various embodiments, the adhesive may be provided onthe bottom surface of the disposable housing 20, with a peelable coverlayer covering the adhesive material. In this manner, the cover layermay be peeled off to expose the adhesive material, and the adhesive sideof the disposable housing 20 may be placed against the user-patient, forexample against the skin of the user-patient. Thus in some embodiments,the delivery device 12 may be attached to the skin of the user-patient.

In other embodiments, the disposable housing 20 and/or the remainingportions of the delivery device 12 may be worn or otherwise attached onor underneath clothing of the user-patient. Similarly, the deliverydevice 12 may be supported by any suitable manner, such as, but notlimited to, on a belt, in a pocket, and the like. Representativeexamples of such delivery devices 12, and delivery devices in general,may include, but is not limited to, the MiniMed Paradigm 522 InsulinPump, MiniMed Paradigm 722 Insulin Pump, MiniMed Paradigm 515 InsulinPump, MiniMed Paradigm 715 Insulin Pump, MiniMed Paradigm 512R InsulinPump, MiniMed Paradigm 712R Insulin Pump, MiniMed 508 Insulin Pump,MiniMed 508R Insulin Pump, and any other derivatives thereof.

The reservoir system 40 may be configured for containing or holdingfluidic media, such as, but not limited to insulin. In variousembodiments, the reservoir system 40 may include a hollow interiorvolume for receiving fluidic media, such as, but not limited to, acylinder-shaped volume, a tubular-shaped volume, or the like. In someembodiments, the reservoir system 40 may be provided as a cartridge orcanister for containing fluidic media. In various embodiments, thereservoir system 40 can be refilled with fluidic media. In furtherembodiments, the reservoir system 40 is pre-filled with fluidic media.

The reservoir system 40 may be supported by the disposable housing 20 inany suitable manner. For example, the disposable housing 20 may beprovided with projections or struts (not shown), or a trough feature(not shown), for holding the reservoir system 40. In some embodiments,the reservoir system 40 may be supported by the disposable housing 20 ina manner that allows the reservoir system 40 to be removed from thedisposable housing 20 and replaced with another reservoir.Alternatively, or in addition, the reservoir system 40 may be secured tothe disposable housing 20 by a suitable adhesive, a strap, or othercoupling structure.

In various embodiments, the reservoir system 40 may include at least oneport 41 for allowing fluidic media to flow into and/or flow out of theinterior volume of the reservoir system 40. In some embodiments, theinfusion path 50 may include a connector 56, a tube 54, and a needleapparatus 52. The connector 56 of the infusion path 50 may beconnectable to the port 41 of the reservoir system 40. In variousembodiments, the disposable housing 20 may be configured with an openingnear the port 41 of the reservoir system 40 for allowing the connector56 of the infusion path 50 to be selectively connected to anddisconnected from the port 41 of the reservoir system 40.

In various embodiments, the port 41 of the reservoir system 40 may becovered with or supports a septum (not shown in FIG. 2), such as aself-sealing septum, or the like. The septum may be configured toprevent fluidic media from flowing out of the reservoir system 40through the port 41 when the septum is not pierced. In addition, invarious embodiments, the connector 56 of the infusion path 50 mayinclude a needle for piercing the septum covering the port 41 of thereservoir system 40 to allow fluidic media to flow out of the interiorvolume of the reservoir system 40.

Examples of needle/septum connectors can be found in U.S. patentapplication Ser. No. 10/328,393, filed Dec. 22, 2003, entitled“Reservoir Connector,” which is incorporated herein by reference in itsentirety. In other alternatives, non-septum connectors such as Luerlocks, or the like may be used. In various embodiments, the needleapparatus 52 of the infusion path 50 may include a needle that is ableto puncture the skin of the user-patient. In addition, in variousembodiments, the tube 54 connects the connector 56 with the needleapparatus 52 and may be hollow, such that the infusion path 50 is ableto provide a path to allow for the delivery of fluidic media from thereservoir system 40 to the body of a user-patient.

The durable housing 30 of the delivery device 12 in accordance withvarious embodiments of the present invention includes a housing shellconfigured to mate with and secure to the disposable housing 20. Thedurable housing 30 and the disposable housing 20 may be provided withcorrespondingly shaped grooves, notches, tabs, or other suitablefeatures that allow the two parts to connect together easily, bymanually pressing the two housings together, by twist or threadedconnection, or other suitable manner of connecting the parts that iswell known in the mechanical arts.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be connected to each other using a twist action. Thedurable housing 30 and the disposable housing 20 may be configured to beseparable from each other when a sufficient force is applied todisconnect the two housings from each other. For example, in someembodiments the disposable housing 20 and the durable housing 30 may besnapped together by friction fitting. In various embodiments, a suitableseal, such as an o-ring seal, may be placed along a peripheral edge ofthe durable housing 30 and/or the disposable housing 20 to provide aseal against water entering between the durable housing 30 and thedisposable housing 20.

The durable housing 30 of the delivery device 12 may support a drivedevice (not shown in FIG. 2), including a motor and a drive devicelinkage portion, for applying a force to fluidic media within thereservoir system 40 to force fluidic media out of the reservoir system40 and into an infusion path, such as the infusion path 50, for deliveryto a user-patient. For example, in some embodiments, an electricallydriven motor may be mounted within the durable housing 30 withappropriate linkage for operatively coupling the motor to a plunger arm(not shown in FIG. 2) connected to a plunger head (not shown in FIG. 2)that is within the reservoir system 40 and to drive the plunger head ina direction to force fluidic media out of the port 41 of the reservoirsystem 40 and to the user-patient.

Also, in some embodiments, the motor may be controllable to reversedirection to move the plunger arm and the plunger head to cause fluid tobe drawn into the reservoir system 40 from a patient. The motor may bearranged within the durable housing 30 and the reservoir system 40 maybe correspondingly arranged on the disposable housing 20, such that theoperable engagement of the motor with the plunger head, through theappropriate linkage, occurs automatically upon the user-patientconnecting the durable housing 30 with the disposable housing 20 of thedelivery device 12. Further examples of linkage and control structuresmay be found in U.S. patent application Ser. No. 09/813,660, filed Mar.21, 2001, entitled “Control Tabs for Infusion Devices and Methods ofUsing the Same,” which is incorporated herein by reference in itsentirety.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be made of suitably rigid materials that maintain theirshape, yet provide sufficient flexibility and resilience to effectivelyconnect together and disconnect, as described above. The material of thedisposable housing 20 may be selected for suitable compatibility withskin. For example, the disposable housing 20 and the durable housing 30of the delivery device 12 may be made of any suitable plastic, metal,composite material, or the like. The disposable housing 20 may be madeof the same type of material or a different material relative to thedurable housing 30. In some embodiments, the disposable housing 20 andthe durable housing 30 may be manufactured by injection molding or othermolding processes, machining processes, or combinations thereof.

For example, the disposable housing 20 may be made of a relativelyflexible material, such as a flexible silicone, plastic, rubber,synthetic rubber, or the like. By forming the disposable housing 20 of amaterial capable of flexing with the skin of a user-patient, a greaterlevel of user-patient comfort may be achieved when the disposablehousing 20 is secured to the skin of the user-patient. In addition, aflexible disposable housing 20 may result in an increase in site optionson the body of the user-patient at which the disposable housing 20 maybe secured.

In the embodiment illustrated in FIG. 2, the delivery device 12 isconnected to the sensing device 14 through a connection element 17 ofthe sensing device 14. The sensing device 14 may include a sensor 15that includes any suitable biological or environmental sensing device,depending upon a nature of a treatment to be administered by thedelivery device 12. For example, in the context of delivering insulin toa diabetes patient, the sensor 15 may include a blood glucose sensor, orthe like.

In some embodiments, the sensor 15 may include a continuous glucosesensor. The continuous glucose sensor may be implantable within the bodyof the user-patient. In other embodiments, the continuous glucose sensormay be located externally, for example on the skin of the user-patient,or attached to clothing of the user-patient. In such embodiments, fluidmay be drawn continually from the user-patient and sensed by thecontinuous glucose sensor. In various embodiments, the continuousglucose sensor may be configured to sense and/or communicate with theCCD 16 continuously. In other embodiments, the continuous glucose sensormay be configured to sense and/or communicate with the CCD 16intermittently, for example sense glucose levels and transmitinformation every few minutes. In various embodiments, the continuousglucose sensor may utilize glucose oxidase.

The sensor 15 may be an external sensor that secures to the skin of auser-patient or, in other embodiments, may be an implantable sensor thatis located in an implant site within the body of the user-patient. Infurther alternatives, the sensor may be included with as a part or alongside the infusion cannula and/or needle, such as for example as shown inU.S. patent application Ser. No. 11/149,119, filed Jun. 8, 2005,entitled “Dual Insertion Set,” which is incorporated herein by referencein its entirety. In the illustrated example of FIG. 2, the sensor 15 isan external sensor having a disposable needle pad that includes a needlefor piercing the skin of the user-patient and enzymes and/or electronicsreactive to a biological condition, such as blood glucose level or thelike, of the user-patient. In this manner, the delivery device 12 may beprovided with sensor data from the sensor 15 secured to the user-patientat a site remote from the location at which the delivery device 12 issecured to the user-patient.

While the embodiment shown in FIG. 2 may include a sensor 15 connectedby the connection element 17 for providing sensor data to sensorelectronics (not shown in FIG. 2) located within the durable housing 30of the delivery device 12, other embodiments may employ a sensor 15located within the delivery device 12. Yet other embodiments may employa sensor 15 having a transmitter for communicating sensor data by awireless communication link with receiver electronics (not shown in FIG.2) located within the durable housing 30 of the delivery device 12. Invarious embodiments, a wireless connection between the sensor 15 and thereceiver electronics within the durable housing 30 of the deliverydevice 12 may include a radio frequency (RF) connection, an opticalconnection, or another suitable wireless communication link. Furtherembodiments need not employ the sensing device 14 and, instead, mayprovide fluidic media delivery functions without the use of sensor data.

As described above, by separating disposable elements of the deliverydevice 12 from durable elements, the disposable elements may be arrangedon the disposable housing 20, while durable elements may be arrangedwithin a separable durable housing 30. In this regard, after aprescribed number of uses of the delivery device 12, the disposablehousing 20 may be separated from the durable housing 30, so that thedisposable housing 20 may be disposed of in a proper manner. The durablehousing 30 may then be mated with a new (un-used) disposable housing 20for further delivery operation with a user-patient.

FIG. 3 illustrates an example of the delivery device 12 in accordancewith another embodiment of the present invention. The delivery device 12of the embodiment of FIG. 3 is similar to the delivery device 12 of theembodiment of FIG. 2. While the delivery device 12 in the embodimentillustrated in FIG. 2 provides for the durable housing 30 to cover thereservoir system 40, the delivery device 12 in the embodiment of FIG. 3provides for the durable housing 30 to secure to the disposable housing20 without covering the reservoir system 40. The delivery device 12 ofthe embodiment illustrated in FIG. 3 includes the disposable housing 20,and the disposable housing 20 in accordance with the embodimentillustrated in FIG. 3 includes a base 21 and a reservoir retainingportion 24. In one embodiment, the base 21 and reservoir retainingportion 24 may be formed as a single, unitary structure.

The base 21 of the disposable housing 20 may be configured to besecurable to a body of a user-patient. The reservoir-retaining portion24 of the disposable housing 20 is configured to house the reservoirsystem 40. The reservoir-retaining portion 24 of the disposable housing20 may be configured to have an opening to allow for the port 41 of thereservoir system 40 to be accessed from outside of thereservoir-retaining portion 24 while the reservoir system 40 is housedin the reservoir-retaining portion 24. The durable housing 30 may beconfigured to be attachable to and detachable from the base 21 of thedisposable housing 20. The delivery device 12 in the embodimentillustrated in FIG. 3 includes a plunger arm 60 that is connected to orthat is connectable to a plunger head (not shown in FIG. 3) within thereservoir system 40.

FIG. 4 illustrates another view of the delivery device 12 of theembodiment of FIG. 3. The delivery device 12 of the embodimentillustrated in FIG. 4 includes the disposable housing 20, the durablehousing 30, and the infusion path 50. The disposable housing 20 in theembodiment of FIG. 4 includes the base 21, the reservoir-retainingportion 24, and a peelable cover layer 25. The peelable cover layer 25may cover an adhesive material on the bottom surface 22 of the base 21.The peelable cover layer 25 may be configured to be peelable by auser-patient to expose the adhesive material on the bottom surface 22 ofthe base 21. In some embodiments, there may be multiple adhesive layerson the bottom surface 22 of the base 21 that are separated by peelablelayers.

The infusion path 50 in accordance with the embodiment of the presentinvention illustrated in FIG. 4 includes the needle 58 rather than theconnector 56, the tube 54, and the needle apparatus 52 as shown in theembodiment of FIG. 2. The base 21 of the disposable housing 20 may beprovided with an opening or pierceable wall in alignment with a tip ofthe needle 58, to allow the needle 58 to pass through the base 21 andinto the skin of a user-patient under the base 21, when extended. Inthis manner, the needle 58 may be used to pierce the skin of theuser-patient and deliver fluidic media to the user-patient.

Alternatively, the needle 58 may be extended through a hollow cannula(not shown in FIG. 4), such that upon piercing the skin of theuser-patient with the needle 58, an end of the hollow cannula is guidedthrough the skin of the user-patient by the needle 58. Thereafter, theneedle 58 may be removed, leaving the hollow cannula in place, with oneend of the cannula located within the body of the user-patient and theother end of the cannula in fluid flow connection with fluidic mediawithin the reservoir system 40, to convey pumped infusion media from thereservoir system 40 to the body of the user-patient.

FIG. 5A illustrates a durable portion 8 of the delivery device 12 (referto FIG. 3) in accordance with an embodiment of the present invention.FIG. 5B illustrates a section view of the durable portion 8 inaccordance with an embodiment of the present invention. FIG. 5Cillustrates another section view of the durable portion 8 in accordancewith an embodiment of the present invention. With reference to FIGS. 5A,5B, and 5C, in various embodiments, the durable portion 8 may includethe durable housing 30, and a drive device 80. The drive device 80 mayinclude a motor 84 and a drive device linkage portion 82.

In various embodiments, the durable housing 30 may include an interiorvolume for housing the motor 84, the drive device linkage portion 82,other electronic circuitry, and a power source (not shown in FIGS. 5A,5B, and 5C). In addition, in various embodiments, the durable housing 30may be configured with an opening 32 for receiving a plunger arm 60(refer to FIG. 3). In addition, in various embodiments, the durablehousing 30 may include one or more connection members 34, such as tabs,insertion holes, or the like, for connecting with the base 21 of thedisposable housing 20 (refer to FIG. 3).

FIG. 6A illustrates a disposable portion 9 of the delivery device 12(refer to FIG. 3) in accordance with an embodiment of the presentinvention. FIG. 6B illustrates a section view of the disposable portion9 in accordance with an embodiment of the present invention. FIG. 6Cillustrates another section view of the disposable portion 9 inaccordance with an embodiment of the present invention. With referenceto FIGS. 6A, 6B, and 6C, in various embodiments, the disposable portion9 includes the disposable housing 20, the reservoir system 40, theplunger arm 60, and a plunger head 70. In some embodiments, thedisposable housing 20 may include the base 21 and thereservoir-retaining portion 24. In various embodiments, the base 21 mayinclude a top surface 23 having one or more connection members 26, suchas tabs, grooves, or the like, for allowing connections with the one ormore connection members 34 of embodiments of the durable housing 30(refer to FIG. 5B).

In various embodiments, the reservoir system 40 may be housed within thereservoir retaining portion 24 of the disposable housing 20, and thereservoir system 40 may be configured to hold fluidic media. Inaddition, in various embodiments, the plunger head 70 may be disposed atleast partially within the reservoir system 40 and may be moveablewithin the reservoir system 40 to allow fluidic media to fill into thereservoir system 40 and to force fluidic media out of the reservoirsystem 40. In some embodiments, the plunger arm 60 may be connected toor is connectable to the plunger head 70.

Also, in some embodiments, a portion of the plunger arm 60 may extend tooutside of the reservoir-retaining portion 24 of the disposable housing20. In various embodiments, the plunger arm 60 may have a mating portionfor mating with the drive device linkage portion 82 of the drive device80 (refer to FIG. 5C). With reference to FIGS. 5C and 6C, in someembodiments, the durable housing 30 may be snap fitted onto thedisposable housing 20, whereupon the drive device linkage portion 82automatically engages the mating portion of the plunger arm 60.

When the durable housing 30 and the disposable housing 20 are fittedtogether with the drive device linkage portion 82 engaging or matingwith the plunger arm 60, the motor 84 may be controlled to drive thedrive device linkage portion 82 and, thus, move the plunger arm 60 tocause the plunger head 70 to move within the reservoir system 40. Whenthe interior volume of the reservoir system 40 is filled with fluidicmedia and an infusion path is provided from the reservoir system 40 tothe body of a user-patient, the plunger head 70 may be moved within thereservoir system 40 to force fluidic media from the reservoir system 40and into the infusion path, so as to deliver fluidic media to the bodyof the user-patient.

In various embodiments, once the reservoir system 40 has beensufficiently emptied or otherwise requires replacement, the user-patientmay simply remove the durable housing 30 from the disposable housing 20,and replace the disposable portion 9, including the reservoir system 40,with a new disposable portion having a new reservoir. The durablehousing 30 may be connected to the new disposable housing of the newdisposable portion, and the delivery device including the new disposableportion may be secured to the skin of a user-patient, or otherwiseattached to the user-patient.

In various other embodiments, rather than replacing the entiredisposable portion 9 every time the reservoir system 40 is emptied, thereservoir system 40 may be refilled with fluidic media. In someembodiments, the reservoir system 40 may be refilled while remainingwithin the reservoir retaining portion 24 (refer to FIG. 6B) of thedisposable housing 20. In addition, in various embodiments, thereservoir system 40 may be replaced with a new reservoir (not shown),while the disposable housing 20 may be re-used with the new reservoir.In such embodiments, the new reservoir may be inserted into thedisposable portion 9.

With reference to FIGS. 3, 5A, 6B, and 6C, in various embodiments, thedelivery device 12 may include reservoir status circuitry (not shown),and the reservoir system 40 may include reservoir circuitry (not shown).In various embodiments, the reservoir circuitry stores information suchas, but not limited to, at least one of (i) an identification stringidentifying the reservoir system 40; (ii) a manufacturer of thereservoir system 40; (iii) contents of the reservoir system 40; and (iv)an amount of contents in the reservoir system 40. In some embodiments,the delivery device 12 may include the reservoir status circuitry (notshown), and the reservoir status circuitry may be configured to readdata from the reservoir circuitry (not shown) when the reservoir system40 is inserted into the disposable portion 9.

In various embodiments, the reservoir status circuitry (not shown) maybe further configured to store data to the reservoir circuitry after atleast some of the contents of the reservoir system 40 have beentransferred out of the reservoir system 40 to update information in thereservoir circuitry (not shown) related to an amount of contents stillremaining in the reservoir system 40. In some embodiments, the reservoirstatus circuitry (not shown) may be configured to store data to thereservoir circuitry (not shown) to update information in the reservoircircuitry (not shown) related to an amount of contents remaining in thereservoir system 40 when the reservoir system 40 is inserted into thedisposable portion 9. In some embodiments, the delivery device 12 mayinclude the reservoir status circuitry (not shown) and the reservoirsystem 40 may include the reservoir circuitry (not shown), and thereservoir status circuitry (not shown) may selectively inhibit use ofthe delivery device 12 or may selectively provide a warning signal basedon information read by the reservoir status circuitry (not shown) fromthe reservoir circuitry (not shown).

Aspects of the present invention relate, generally, to needle inserteror inserting devices and methods and medical devices, such as, but notlimited to sensors, monitors and infusion medium delivery systems,devices and methods that include such needle-inserting devices andmethods. The needle-inserting device and method may operate to insert aneedle or cannula through skin of a user-patient, for example, toprovide a fluid flow path for conveying an infusion medium through ahollow channel in the needle or cannula and into the user-patient and/orto convey a fluid from the user-patient to one or more sensor elements.Embodiments of the present invention may be configured, as describedherein, to provide a reliable, cost effective, and easy-to-use mechanismfor inserting a needle or cannula to a specific depth into auser-patient with minimal traumatic effect.

In addition, embodiments may be configured to establish a contiguousfluid flow passage for fluid transfer between a reservoir and theuser-patient when the hollow needle or cannula is inserted into theuser-patient. Needle-inserting devices according to embodiments of thepresent invention may be used with, connectable to and disconnectablefrom, or incorporated in a portion of an infusion medium deliverysystem. For example, a needle-inserting device may be connectable to abase structure of a pump-type delivery device for insertion of a needle,after which the needle-inserting device may be removed from the basestructure, whereupon a further housing portion of the delivery device(containing components such as, but not limited to, a reservoir and pumpor drive device) may be coupled to the base structure for operation.

Alternatively, the needle-inserting device may be incorporated into thefurther housing portion that contains other components as describedabove. In yet other embodiments, the needle-inserting device may beconnectable to (and releasable from) or incorporated within an injectionsite module or other housing that connects, for example, by flexibletubing, to other components of a medical device (such as, but notlimited to an infusion medium delivery device). In yet otherembodiments, needle inserter devices may be configured for use withsystems other than infusion medium delivery systems, such as, but notlimited to sensor and monitor systems, or the like.

The structures and methods described with respect to FIGS. 7-25 may beemployed in any suitable device or system in which two members that, atsome period of time, are not connected in fluid flow communication, areto be connected together in a manner that allows fluid to flow from onemember to the other. In one example embodiment, the structure and methodis described with respect to a first member including a fluid reservoirfor containing an infusion medium that may be connectable to a secondmember including an injection site structure in which a hollow needle orcannula is or may be inserted into a user-patient, for conveying fluidmedia to the user-patient. However, a connection structure according toembodiments of the present invention may be employed to connect any two(or more) members together for fluid flow communication with each other.

In FIGS. 7-12, an example of a structure 100 and method for connectingtwo members in fluid flow communication is described with reference to afirst member 102 and a second member 103. The first member 102 mayinclude a housing 104 on a base 106. The housing 104 may be formedintegral with the base 106 or may be formed as a separate structureconnected to the base 106 in a fixed relation to the base 106. Thehousing 104 and the base 106 each may be made of any suitably rigidmaterial, including, but not limited to plastic, metal, ceramic,composite material, or the like.

The housing 104 may include an injection site section 105 containing aninjection site structure in which a hollow needle or cannula may beinserted into a user-patient for conveying fluidic media to or from theuser-patient. The housing 104 may be made of a material of suitablestrength and durability such as, but not limited to, plastic, metal,glass, or the like. In other embodiments, instead of or in addition toan injection site, the housing 104 may contain, be part of, or beoperatively connected to any other suitable structure for conveying,containing, and/or processing fluidic media.

The second member 103 may also include a housing 108, which in theillustrated embodiment may include a reservoir 107 for containingfluidic media. The reservoir 107 may be configured and/or made ofmaterials as previously described with respect to reservoir system 40(e.g., FIGS. 1-6C). The second member 103 may be held within orotherwise be covered by an outer housing 109 configured to attach to thebase 106. The outer housing 109 may be configured to connect to the base106 of the first member 102 by any suitable connection structure.

In particular embodiments, at least one of the outer housing 109 and thebase 106 may include one or more flexible pawls, protrusions,indentations, or the like for engaging and/or receiving one or morecorresponding pawls, protrusions, indentations, or the like on the otherof the base 106 and the outer housing 109 to provide a suitableconnection structure. Alternatively or in addition, the connectionstructure may include adhesive material or other suitable connectors.

In other embodiments, the housing 108 may be or be connected to a sensorhousing (not shown) containing sensor components. In yet otherembodiments, the housing 108 may contain, be part of, or be operativelyconnected to any other suitable structure for conveying, containing,and/or processing fluidic media. The housing 108 may be made of anysuitably rigid material, including, but not limited to, plastic, metal,ceramic, composite material, or the like.

The housing 104 may have or be connected to a receptacle structure 110.The receptacle structure 110 may have an opening 112 leading into achamber 114 within the receptacle structure 110. In some embodiments,the receptacle structure 110 may be part of the housing 104 adjacent asection of the housing 104 containing the injection site section 105. Inother embodiments, the receptacle structure 110 may include a furtherhousing connected to the housing 104.

The receptacle structure 110 may include a first septum 116 locatedwithin the chamber 114 and may be moveable within the chamber 114 towardand away from the opening 112. The receptacle structure 110 may alsoinclude a bias mechanism 118, which may apply a bias force on the firstseptum 116 in a direction toward the opening 112. The bias mechanism 118may be arranged for forcing the first septum 116 against the opening112. One or more annular protrusions or one or more appropriately shapedor positioned protrusions 120 adjacent the opening 112 may be providedto inhibit the first septum 116 from being forced out of the chamber 114through the opening 112 by the force of the bias mechanism 118.

The first septum 116 may have a front surface 116 a that is at leastpartially exposed through the opening 112 when the first septum 116 isurged against the opening 112 by the bias mechanism 118. The firstseptum 116 may have a back surface 116 b facing toward an interior ofthe chamber 114. The first septum 116 may be made of any suitablematerial that may be pierceable by a needle, such as, but not limitedto, a natural or synthetic rubber material, silicon, or the like. Insome embodiments, the first septum 116 may be made of a self-sealingmaterial capable of sealing itself after a needle has pierced the firstseptum 116 and was subsequently withdrawn from the first septum 116.

In some embodiments, the bias mechanism 118 may be a coil spring locatedwithin the chamber 114 on an opposite side of the first septum 116 withrespect to the front surface 116 a. In other embodiments, the biasmechanism 118 may be provided in any suitable manner for biasing thefirst septum 116 toward the opening 112. These may include, but are notlimited to, other types of springs, pressurized fluid within the chamber114, a collapsible skirt structure extending from the first septum 116with a natural or built-in spring force, chemical, substance thatexpands upon contact with another chemical or substance, or uponapplication of energy from an energy source such as a heat, laser, orother radiation source, or the like. For example, in some embodiments,the first septum 116 may have a flexible accordion-like configuration toallow expansion and contraction of the skirt structure.

A needle 124 may be supported within the chamber 114. The needle 124 maybe hollow and may have a sharp end 124 a directed toward the backsurface 116 b of the first septum 116. In some embodiments, the needle124 may be supported within the bias mechanism 118 such that alongitudinal axial dimension of the needle 124 extends generallyparallel to a longitudinal axial dimension of the bias mechanism 118.

The needle 124 may be supported by a supporting structure located withinthe receptacle structure 110. In some embodiments, the supportingstructure may be a wall integral with the receptacle structure 110. Thesupporting structure may be located, for example, on an opposite end ofthe chamber 114 relative to the end of the chamber 114 at which theopening 112 is located. In other embodiments, the supporting structuremay be any suitable structure that is generally fixed relative to thereceptacle structure 110 and is able to support the needle 124 in agenerally fixed relation to the receptacle structure 110.

The needle 124 may be made of any suitably rigid material, including,but not limited to metal, plastic, ceramic, or the like, and may have ahollow channel extending in a lengthwise dimension of the needle 124.The hollow channel in the needle 124 may be open on the sharp end 124 aof the needle 124 and may be open at another location 124 b along thelengthwise dimension of the needle 124, such as, but not limited to, theneedle end opposite the sharp end 124 a. The hollow channel in theneedle 124 may provide a fluid flow path between the sharp end 124 a ofthe needle 124 and the opening 124 b of the needle 124. In someembodiments, the opening 124 b of the needle 124 may be connected influid flow communication with a manifold 128 in the injection sitesection 105.

The housing 108 of the second member 103 may include a connectionportion 130 having a hollow interior chamber 132 and an opening 134 intothe interior chamber 132. A second septum 136 may be supported by thehousing 108 to seal the opening 134. The second septum 136 may besupported in a fixed relation to the housing 108, for example, withinthe housing 108 at one end of the interior chamber 132.

The connection portion 130 of the housing 108 may have a suitable shapeand size to fit at least partially within the opening 112 of thereceptacle structure 110 in the first member 102 when the first member102 and the second member 103 are connected together. In the drawings ofFIGS. 7 and 8, the first member 102 and the second member 103 are shownin a separated, disconnected relation, wherein the connection portion130 of the housing 108 is outside of the opening 112 of the receptaclestructure 110. By moving the first member 102 and the second member 103together to insert the connection portion 130 into the opening 112 ofthe housing 108 an end surface of the connection portion 130 may beurged against the first septum 116. This may cause the moveable firstseptum 116 to move relative to the housing 108 against the force of thebias mechanism 118 toward the interior of the chamber 114. As the firstseptum 116 is moved toward the interior of the housing 108, the sharpend 124 a of the needle 124 may pierce the first septum 116. Continuedrelative movement of the first member 102 and the second member 103together may cause the sharp end 124 a of the needle 124 to pass throughthe first septum 116 in the first member 102, then pierce, and passthrough the second septum 136 in the second member 103.

When the first member 102 and the second member 103 are brought together(e.g., FIG. 9), at least a portion of the connection portion 130 mayextend inside of the receptacle structure 110. With reference to FIGS. 8and 9, the needle 124 may pierce the first septum 116 and the secondseptum 136 to form a fluid flow path between the interior chamber 132 ofthe connection portion 130 and the manifold 128 or other structure atthe opening 124 b of the needle 124. The receptacle structure 110 andthe connection portion 130 may be provided with mating connectors thatprovide, for example, a snap or friction connection upon the firstmember 102 and the second member 103 being brought together as shown inFIG. 9. In some embodiments, the mating connectors may include aprotrusion (not shown) on one or the other of the receptacle structure110 and the connection portion 130. The other of the receptaclestructure 110 and the connection portion 130 may include a groove orindentation (not shown) arranged to engage each other in a snap-fittingmanner upon the connection portion 130 being extended into thereceptacle structure 110 a suitable distance.

As mentioned above, in some embodiments, the opening 124 b of the needle124 may be connected in fluid flow communication with the manifold 128in the injection site section 105. The injection site section 105 mayinclude a channel 140 extending through the housing 104 and the base106. The channel 140 may have an open end 140 a on a bottom surface(relative to the orientation shown in FIG. 8) of the base 106. Thechannel 140 may have another open end 140 b at an upper surface(relative to the orientation shown in FIG. 8) of the injection sitesection 105 of the housing 104.

The manifold 128 may be located along a length of the channel 140 andmay be in fluid flow communication with the channel 140. Accordingly,the needle 124 may be arranged in fluid flow communication with theinterior of the channel 140 through the manifold 128. The channel 140may include a channel section 142 having a larger radial dimensionrelative to a remaining portion of the channel 140 and may have asuitable shape and size to receive a needle and/or cannula, as will bedescribed later. The manifold 128 may be made of a material of suitablestrength and durability such as, but not limited to, plastic, metal,glass, or the like.

A needle-inserting device 144 may be located adjacent the open end 140 bof the channel 140 and arranged to selectively extend a needle and/orcannula into the open end 140 b of the channel 140 and at leastpartially through the channel 140 as will be described. In variousembodiments, the needle-inserting device 144 may be configured to beintegral with or otherwise fixed to the section 105 of the housing 104of the first member 102. In other embodiments, the needle-insertingdevice 144 may be a separate device from the housing 104 and may beselectively engaged or connected to, for example in alignment with thechannel 140 (e.g., FIG. 8), and disengaged or disconnected from theinjection site section 105 of the housing 104.

In embodiments in which the needle-inserting device 144 is a separatestructure that connects to and disconnects from the injection sitesection 105, a suitable connection structure may be provided on theneedle-inserting device 144 and/or the injection site section 105 toprovide a manually releasable connection between those components. Forexample, the connection structure may include, but is not limited to, athreaded extension on one or the other of the needle-inserting device144 and the injection site section 105 and a corresponding threadedreceptacle on the other of the injection site section 105 and theneedle-inserting device 144 for receiving and mating with the threadedextension in threaded engagement. In other embodiments, other suitableconnection structures may be employed, including, but not limited to,flexible pawls or extensions on one or the other of the needle-insertingdevice 144 and the injection site section 105 and a correspondingaperture, stop surface, or the like on the other of the other of theinjection site section 105 and the needle-inserting device 144 orfriction fitting engageable portions on each of the section 105 andneedle-inserting device 144.

In the drawing of FIG. 8, the needle-inserting device 144 is shown asconnected to the injection site section 105 with a needle 146 and acannula 148 in a retracted state. With reference to FIGS. 7-16, theneedle-inserting device 144 may be operated to selectively move theneedle 146 and the cannula 148 from the retracted state (e.g., FIG. 8)to an extended state (e.g., FIG. 13) in which the needle 146 and thecannula 148 extend through the opening 140 b of the channel 140 and atleast partially through the channel 140 such that a sharp end 146 a ofthe needle 146 and at least a portion of the length of the cannula 148extend out the opening 140 a of the channel 140.

Various examples of suitable structures for needle-inserting devices aredescribed in U.S. patent application Ser. No. 11/645,435, filed Dec. 26,2006, entitled “Infusion Medium Delivery System, Device And Method WithNeedle Inserter And Needle Inserter Device And Method,” which isassigned to the assignee of the present invention and is incorporatedherein by reference in its entirety. Further examples of variousneedle-inserting devices are described in, but are not limited to, U.S.patent application Ser. No. 11/645,972, filed Dec. 26, 2006, “InfusionMedium Delivery System, Device And Method With Needle Inserter AndNeedle Inserter Device And Method”; U.S. patent application Ser. No.11/646,052, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; U.S. patent application Ser. No. 11/645,435, filed Dec. 26,2006, “Infusion Medium Delivery System, Device And Method With NeedleInserter And Needle Inserter Device And Method”; U.S. patent applicationSer. No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method,”, all of which are herein incorporated by referencein its entirety. Other examples of suitable structures forneedle-inserting devices are described herein.

The cannula 148 may have a hollow central channel 148 c extending alonga longitudinal length of the cannula 148 and open at one end 148 a thatmay be adjacent the sharp end 146 a of the needle 146. An end 148 b ofthe cannula 148 opposite the open end 148 a may have a head 150 having alarger radial dimension than a shaft portion 148 d of the cannula 148.The cannula head 150 may have a suitable shape and size to fit into thechannel section 142 of the channel 140 when the needle 146 and thecannula 148 are moved to the extended state by the needle-insertingdevice 144.

In particular embodiments, the cannula head 150 may include one or moreprotrusions and/or indentations for engaging one or more correspondingindentations and/or protrusions in the channel section 142 of theinjection site section 105 to provide a friction fit, snap fit, or thelike. Accordingly, the cannula 148 may be locked or retained within theinjection site section 105 upon the needle 146 and cannula 148 beingmoved to the extended state by the needle-inserting device 144. Infurther embodiments, instead of or in addition to engaging protrusionsand indentations, one or more other mechanical structures may beemployed to provide a suitable retaining function for retaining thecannula 148 in place within the injection site section 105, including,but not limited to, a friction fit structure, snap fit, or the like.

The cannula 148 may have a connection channel 152 provided in fluid flowcommunication with the hollow central channel 148 c of the cannula 148.The connection channel 152 may be provided along the longitudinal lengthof the cannula 148 at a location at which the connection channel 152aligns with the manifold 128 (i.e., in fluid flow communication with aninterior of the manifold 128) when the needle 146 and the cannula 148have been moved to the extended state by the needle-inserting device144. In this manner, upon the cannula 148 being moved to the extendedstate, the hollow central channel 148 c of the cannula 148 may bearranged in fluid flow communication with the reservoir 108 through themanifold 128 and the connection channel 152.

Thus, according to some embodiments, in operation, a first member 102,which may include, for example, a housing 104 having a receptacle 110and an injection site section 105, may be coupled together with a secondmember 103, which may include, for example, a housing 108 having areservoir 107. The first member 102 may be coupled or otherwiseoperatively connected, by inserting a connection portion 130 of thesecond member 103 into a receptacle 110 of the first member 102. Uponcoupling the first member 102 and the second member 103, fluid flowcommunication may be provided between the second member 103 and theinjection site section 105 in the first member 102.

In various embodiments, the needle-inserting device 144 may be coupledto the injection site section 105 of the housing 104 of the first member102 or may be provided as part of a single, unitary structure (i.e.,integral) with the injection site section 105 of the housing 104. Insome embodiments, the base 106 of the first member 102 may be secured toskin of a user-patient at a suitable injection location with, forexample, but not limited to, adhesive material as described in U.S.patent application Ser. No. 11/645,435, filed Dec. 26, 2006, entitled“Infusion Medium Delivery system, Device And Method With Needle InserterAnd Needle Inserter Device And Method,” and/or as described herein.Alternatively or in addition, the base 106 may be secured to theuser-patient by one or more other suitable structures, including, butnot limited to, straps, or the like.

Once the base 106 is suitably secured to the skin of the user-patient ata suitable injection location, the inserting device 144 may be actuatedto move the needle 146 and the cannula 148 from a retracted state (e.g.,FIG. 8) to an extended state. In the extended state, the needle 146and/or the cannula 148 may pierce the skin of the user-patient adjacentthe base 106. The cannula 148 may be locked into its extended state byengagement of the cannula head 150 and the channel section 142, aspreviously described.

With the cannula 148 locked in the extended state, the needle 146 may beretracted, for example, by automatic operation of the needle-insertingdevice 144 and/or by manual removal of the needle-inserting device 144from the injection site section 105. Once the needle 146 is removed, thecannula 148 may be held in place by the injection site section 105 witha portion of the cannula 148 extending into the user-patient. As such,the cannula 148 may be connected in fluid-flow communication with theneedle 124. Accordingly, by connecting the first member 102 and thesecond member 103, as described above, then a fluid-flow connection maybe provided from the reservoir 107 to the cannula 148 through the needle124 and the manifold 128.

A connection sequence (e.g., the sequence of connecting theneedle-inserting device 144 to the injection site section 105 of thehousing 104, connecting the receptacle 110 of the housing 104 to theconnection portion 130 of the housing 108 having the reservoir 107, andconnecting the base 106 of the first member 102 to the skin of theuser-patient) for connecting various components may be different fordifferent embodiments. In some embodiments, the user-patient may beprovided with a first member 102 having a base 106, a housing 104, andan injection site section 105 in a pre-connected state with theneedle-inserting device 144. In this manner, a user-patient need nothave to connect the needle-inserting device 144 to the housing 104 asthose parts are supplied to the user in a pre-connected state, forexample, from a manufacturing or assembly facility. In such embodiments,the base 106 of the first member 102 may be secured to skin of theuser-patient at a suitable injection location. After securing the base106 to the skin of the user-patient, the needle-inserting device 144 maybe activated to cause the needle 146 and the cannula 148 to be moved tothe extended state and pierce the skin of the user-patient.

After activation of the needle-inserting device 144, theneedle-inserting device 144 may be removed from the injection sitesection 105, thus leaving the cannula 148 in place within the injectionsite section 105 and partially extended into the user-patient. With thebase 106 of the first member 102 secured to the skin of the user-patientand the cannula 148 inserted at least partially into the user-patientand arranged in fluid-flow communication with the needle 124, the secondmember 103 may be connected to the first member 102. In particular, theconnection portion 130 of the housing 108 of the second member 103 maybe inserted into the receptacle 110 of the housing 104 of the firstmember 102 to provide a fluid-flow connection between the interior ofthe housing 108 and the needle 124 and, thus, the cannula 148.Accordingly, the housing 108, which may include the reservoir 107, forexample, may be coupled in fluid-flow communication with the cannula 148that has been extended into the user-patient for delivering fluid fromthe reservoir 107 to the user-patient. In other embodiments, such aconnection may be for conveying fluid from the user-patient to thereservoir 107.

While the connection sequence in some of the above embodiments involvesecuring the base 106 of the first member 102 to the user-patient priorto connection of the second member 103 to the first member 102, in otherembodiments, the second member 103 may be connected to the first member102, as described above, prior to securing the base 106 of the firstmember 102 onto the skin of the user-patient. In such embodiments, thefirst member 102 and the second member 103 may be connected togetherand, thereafter, may be secured to the user-patient, for example, byadhering one or both of the first member 102 and the second member 103to the skin of the user-patient. In addition, while the connectionsequence in the above embodiments involve activating theneedle-inserting device 144 prior to the connection of the second member103 to the first member 102, in other embodiments, the second member 103may be connected to the first member 102, as described above, prior toactivating the needle-inserting device 144.

In some embodiments, such as the embodiments shown in FIGS. 7 and 8, thereceptacle 110 may be in the first member 102 and the connection portion130 may be in the second member 103. In other embodiments, thereceptacle 110 may be in the second member 103, for example, in orassociated with a housing for a reservoir and the connection portion 130may be in the first member 102, for example, in or associated with ahousing containing an injection site structure.

In some embodiments, such as the embodiments shown in FIGS. 7 and 8, thereceptacle 110 may be arranged to allow the connection portion 130 ofthe second member 103 to be inserted in a direction substantiallyparallel to a plane of an upper-facing (in the orientation of FIG. 7)surface of the base 106. For example, in the orientation of FIG. 7, thedirection of insertion is shown as a horizontal direction of relativemotion between the first member 102 and the second member 103.

Again referring to FIGS. 7 and 8, in other embodiments, the receptacle110 may be arranged in other suitable orientations, including, but notlimited to, an orientation allowing an insertion direction (i.e.,relative motion of the first member 102 and the second member 103) to besubstantially perpendicular to the plane of the upper-facing surface ofthe base 106. In yet other embodiments, the receptacle 110 may bearranged to allow any other suitable insertion direction at anon-perpendicular angle transverse to the plane of the upper-facingsurface of the base 106.

An example arrangement shown in FIGS. 13-16 provides an insertiondirection (i.e., relative motion of the first member 102 and the secondmember 103) that may be substantially perpendicular to the plane of theupper-facing (in the orientation of FIG. 8) surface of the base 106.Components in FIGS. 13-16 are identified by reference numbers that arethe same as reference numbers used in FIGS. 7-12 for components havingsimilar structure and function. In FIGS. 13 and 14, the injection sitesection 105 in the housing 104 is shown in a state after aneedle-inserting device has been operated to move a cannula 148 to theextended position.

FIGS. 15 and 16 show the base 106 of the first member 102 (of theembodiment of FIGS. 13 and 14) with a needle-inserting device 144attached to the housing 104. The needle-inserting device 144 may includea housing 160 adapted to be securable to the base 106 in any suitablemanner, such as, but not limited to the manners of connecting aneedle-inserting device 144 to the injection site structure 105discussed above with respect to the embodiment of FIGS. 7-12. Returningto FIGS. 15 and 16, the housing 160 may contain an internal chamberhaving a longitudinal dimension L and a moveable plunger 162 locatedwithin the housing 160 and moveable along the longitudinal dimension Lfrom a retracted position (shown in solid lines in FIG. 16) to anextended position (in which the plunger 162 is moved to a position Eshown in broken lines in FIG. 16).

A bias member 164, such as, but not limited to, a coil spring arrangedwithin the housing 160 may be configured to impart a bias force on theplunger 162 when the plunger 162 is in the retracted position to urgethe plunger 162 toward the extended position E. A locking mechanism (notshown) may be provided such as, but not limited to, a manually moveableprojection, lever, slider, or the like, connected to or extendingthrough the housing 160 and engages the plunger 162 or other structureholding the plunger 162 in a releasable manner to selectively hold theplunger 162 in its retracted state against the bias force of the biasmember 164 and to allow a user-patient to selectively release theplunger 162 to move in the longitudinal direction L under the force ofthe bias member 164.

An insert structure 166 may be arranged within the housing 160 formovement in the longitudinal direction L by action of movement of theplunger 162. The insert structure 166 may include, for example, acup-shaped body 168. The cup-shaped body 168 may be made of a materialof suitable strength and durability such as, but not limited to,plastic, metal, glass, or the like. The cup-shaped body 168 may hold afirst septum 116. The septum 116 may be made of a material such assilicone, rubber, plastic, a resealable membrane, or the like.

A hollow cannula 148 may have one open end 148 a and a sharp tiparranged adjacent the first septum 116 or at least partially within thefirst septum 116. The hollow cannula 148 may extend through thecup-shaped body 168 and may have a second open end 148 b. The hollowcannula 148 may be fixed to the cup-shaped body 168 to move withmovement of the cup-shaped body 168. A needle 170 may be secured to theplunger 162 and may extend through the first septum 116 and cannula 148when the plunger 162 is in the retracted position.

In operation, the user-patient (or medical practitioner) may secure thebase 106 to skin of the user-patient, for example, as previouslydescribed. Once the base 106 is secured to the skin of the user-patient,the user-patient (or medical practitioner) may activate theneedle-inserting device 144 to cause the plunger 162 to move from theretracted position to the extended position E and, as a result of suchmovement, to cause the insert structure 166 to be moved into an openinginto the interior of the housing 104. Upon movement of the insertstructure 166 into the housing 104, the insert structure 166 may connectto the housing 104 by any suitable connection structure.

As discussed above, in particular embodiments, one or the other of thecup-shaped body 168 of the insert structure 166 and the housing 104 mayinclude one or more flexible pawls, protrusions, indentations, or thelike, for engaging and receiving one or more corresponding pawls,protrusions, indentations, or the like, on the other of the housing 104and the insert structure 166 to provide a suitable connection structure.Alternatively or in addition, the connection structure may includeadhesive material or other suitable connectors.

In particular embodiments, the housing 160 of the needle-insertingdevice 144 may automatically release from the base 106 upon movement ofthe plunger 162 and the insert structure 166 from the retracted positionto the extended position E. For example, the housing 160 of theneedle-inserting device 144 may be made of a material that hassufficient rigidity to operate as described herein, but also has asuitable flexibility (at least at the portion of the device 144 thatconnects to the housing 104) to bend away from and release from thehousing 104 upon movement of the insert structure 166 to the extendedposition E.

In some embodiments, such as the embodiment shown in FIG. 16, a portion172 of the internal surface of the housing 160 may include a ramped,wedge-shaped, or angled (relative to an axial direction of the housing144, cannula 148, and needle 170) cross-sectional shape that engages anouter peripheral surface of the insert structure 166 and/or the plunger162 as the insert structure 166 and plunger 162 are moved toward theextended position E. By engaging the angled, ramped, or wedge-shapedportion 172 of the internal surface of the housing 160, the plunger 162and/or the insert structure 166 may cause the wall(s) of the housing 160to flex outward as the plunger 162 and/or insert structure 166 are movedinto the extended position. One or more slots, grooves, or the like 174may be formed in the housing 166 to enhance the ability of the wall(s)of the housing 160 to flex outward. One or more protrusions 176 and/orindentations may be provided on one or the other of the interior surfaceof the housing 166 and the exterior surface of the housing 104 forengaging one or more corresponding indentations 178 and/or protrusionsin the other of the housing 104 and housing 166 when the plunger 162 andinsert structure 166 are in the retracted state shown in FIG. 16.

The one or more protrusions 176 and the one or more indentations 178,when engaged, may lock the housing 160 of the needle-inserting device144 to the housing 104. The one or more protrusions 176 and/orindentations 178 may disengage from each other when the wall(s) of thehousing 160 are flexed outward by the movement of the plunger 162 andthe insert structure 166 to the extended position E. As a result, thehousing 160 of the needle-inserting device 144 may be automaticallydisengaged and released from the housing 104 upon movement of theplunger 162 and insert structure 166 to the extended position E.

After movement of the plunger 162 and insert structure 166 from theretracted position (shown in FIG. 16) to the extended position E atwhich the insert structure 166 may be locked into the housing 104, whilethe housing 160 of the needle-inserting device 144 is released from thehousing 104, the bias member 164 (or a second bias member (not shown))may act on the needle 170 to move the needle 170 toward the retractedposition and, thus, withdraw the needle 170 from the cannula 148. Forexample, a return motion of the coil spring after moving from theretracted position to the extended position E may provide sufficientforce to withdraw the needle 170 from the cannula 148.

Once the insert structure 166 has been locked into place within thehousing 104 and the needle-inserting device 144 has been removed fromthe housing 104, the cannula 148 may be connected in fluid-flowcommunication with a connection portion 130 of a second member such as,but not limited to, a reservoir, in a manner similar to the manner inwhich the first member 102 and the second member 103 are connectable inthe embodiments of FIGS. 7-12. More specifically, the housing 104 mayform a receptacle (similar to the receptacle 110 described above forFIGS. 7-12) and may contain the first septum 116.

Similar to the embodiment of FIGS. 7-12, the connection portion 130 mayalso include a second septum 136. In particular, the connection portion130 may be inserted into the receptacle formed by the housing 104 toconnect the interior of the reservoir in fluid-flow communication withthe cannula 148. The cannula 148 in FIG. 13 may include a sharp end 148a adjacent the first septum 116. As the connection portion 130 isinserted into the housing 104, the connection portion may push the firstseptum 116 against the sharp end 148 a of the cannula 148 to cause thesharp end 148 a of the cannula 148 to pierce the first septum 116.Further insertion motion of the connection portion 130 into the housing104 may cause the sharp end 148 a of the cannula 148 to pierce thesecond septum 136 in the connection portion 130 to form a flow path fromor to the connection portion 130 through the cannula 148.

FIGS. 17-20 illustrate an inserting system 200 according to anembodiment of the present invention. FIG. 21 illustrates a process forusing the inserting system 200. Although the inserting system 200 may besimilar or used with the embodiments of FIGS. 1-16, it should beunderstood that the inserting system 200 may also include some or all ofthe same components and operate in a manner similar to that shown anddescribed in the embodiments of FIGS. 22-43. In addition, some or all ofthe features shown in FIGS. 1-16 and 22-43 may be combined in variousways and included in the embodiments and process shown in FIGS. 17-21.Likewise, it should be understood that any of the features of theembodiments and process of FIGS. 17-21 may be combined or otherwiseincorporated into any of the other embodiments and process of FIGS.17-21 as well as any other embodiment herein discussed.

The inserting system 200 may include a first member 202, which may besimilar to the first member 102 (e.g., FIGS. 7-12). The first member 202may include a housing 204 on a base 206. The housing 204 may be formedintegral with the base 206 or may be formed as a separate structureconnected to the base 206 in a fixed relation to the base 206. Thehousing 204 and the base 206 each may be made of any suitably rigidmaterial, including, but not limited to plastic, metal, ceramic,composite material, or the like.

The housing 204 may include an injection site section 205 containing aninjection site structure in which a hollow needle or cannula may beinserted into a user-patient for conveying fluidic media to or from theuser-patient. In other embodiments, instead of or in addition to aninjection site, the housing 204 may contain, be part of, or beoperatively connected to any other suitable structure for conveying,containing, and/or processing fluidic media.

The first member 202 may be operatively connectable to a second member(not shown), which may be similar to the second member 103 (e.g., FIGS.7-12). As previously described with respect to FIGS. 7-12, the secondmember may also include a housing 108, which in the illustratedembodiment may include a reservoir 107 for containing fluidic media. Thesecond member may be held within or otherwise be covered by an outerhousing 109 configured to attach to the base 106. The outer housing 109may be configured to connect to the base 206 (FIGS. 17-20) of the firstmember 202 (FIGS. 17-20) by any suitable connection structure. In someembodiments, upon coupling the first member 202 and the second member,fluid flow communication may be provided between the second member andthe injection site section 205 in the first member 202.

In particular embodiments, at least one of the outer housing 109 and thebase 206 (FIGS. 17-20) may include one or more flexible pawls,protrusions, indentations, or the like for engaging and/or receiving oneor more corresponding pawls, protrusions, indentations, or the like onthe other of the base 206 (FIGS. 17-20) and the outer housing 109 toprovide a suitable connection structure. Alternatively or in addition,the connection structure may include adhesive material or other suitableconnectors.

Returning to FIGS. 17-20, the housing 204 may have or be connected to areceptacle structure 210 having a chamber 214. The receptacle structure210 may be similar to the receptacle structure 110 (e.g., FIGS. 7-12)previously described. In some embodiments, the receptacle structure 210may be part of the housing 204 adjacent a section of the housing 204containing the injection site section 205. In other embodiments, thereceptacle structure 210 may include a further housing connected to thehousing 204.

A fluid conduit 224, such as, but not limited to, a needle or the likemay be supported within the chamber 214. The fluid conduit 224 may besupported by a supporting structure located within the receptaclestructure 210. In some embodiments, the supporting structure may be awall integral with the receptacle structure 210. In other embodiments,the supporting structure may be any suitable structure that is generallyfixed relative to the receptacle structure 210 and is able to supportthe fluid conduit 224 in a generally fixed relation to the receptaclestructure 210.

The fluid conduit 224 may be made of any suitably rigid material,including, but not limited to metal, plastic, ceramic, or the like, andmay have a hollow channel extending in a lengthwise dimension of thefluid conduit 224. The hollow channel in the fluid conduit 224 may beopen at a location (not shown) along the lengthwise dimension of thefluid conduit 224, such as, but not limited to, a first end of the fluidconduit 224. The hollow channel in the fluid conduit 224 may be open atanother location 224 b along the lengthwise dimension of the fluidconduit 224, such as, but not limited to, a second end of the fluidconduit 224 opposite the first end of the fluid conduit 224. One of theopenings in the fluid conduit 224 may be provided with a septum 226 thatmay be pierceable by a needle (not shown), for example as previouslydescribed, when a reservoir is connected to the first member 202.

The injection site section 205 may include a channel 240 extendingthrough the housing 204 and the base 206. The channel 240 may have anopen end 240 a on a bottom surface (relative to the orientation shown inFIG. 18) of the base 206. The channel 240 may have another open end 240b at an upper surface (relative to the orientation shown in FIG. 18) ofthe injection site section 205 of the housing 204. The channel 240 mayinclude a channel section 242 having a larger radial dimension relativeto a remaining portion of the channel 240 and may have a suitable shapeand size to receive an insert structure, a needle, and/or a cannula, aswill be described.

The insertion system 200 may include an insertion housing 280. Theinsertion housing 280 may be made of a material of suitable strength anddurability such as, but not limited to, plastic, metal, glass, or thelike. The insertion housing 280 may be located adjacent the open end 240b of the channel 240 and arranged to selectively extend a needle and/orcannula of an insert structure into the open end 240 b of the channel240 and at least partially through the channel 240 as will be described.

The insertion housing 280 may be a separate device from the housing 204and may be selectively engaged or connected to, for example in alignmentwith the channel 240, and disengaged or disconnected from the injectionsite section 205 and/or the first member 202 or portion thereof. In someembodiments, the insertion housing 280 may be recommended for disposalafter a specified number of uses.

In the drawing of FIG. 18, the insertion housing 280 is shown asconnected to the injection site section 205. With reference to FIGS.17-20, a suitable connection structure may be provided on the insertionhousing 280, the injection site section 205, and/or the first member 202or portion(s) thereof to provide a manually releasable connectionbetween those components. For example, the connection structure mayinclude, but is not limited to, a threaded extension on one or the otherof the insertion housing 280 and the injection site section 205 and acorresponding threaded receptacle on the other of the injection sitesection 205 and the insertion housing 280 for receiving the threadedextension in threaded engagement. In other embodiments, other suitableconnection structures may be employed. These may include, but are notlimited to, friction-fitted sections, flexible pawls or extensions onone or the other of the insertion housing 280 and the injection sitesection 205 (or the first member 202 or portion thereof) and acorresponding aperture, stop surface, or the like on the other of theinjection site section 205 (or the first member 202 or portion thereof)and the insertion housing 280.

In some embodiments, the insertion housing 280 may include one or morearm 281 a having an end 281 b and/or a locking surface 281 d adapted tooperatively engage with and disengage from the first member 202, such asan aperture 205 a and/or a retaining surface 205 b, respectively, of theinsertion site section 205, or the like. The arm 281 a may be made ofany suitably rigid material, such as plastic, glass, metal, compositematerial, ceramic, and/or the like. In some embodiments, the arm 281 amay be made of similar material as the insertion housing 280. In otherembodiments, the arm 281 a may be made of different material from theinsertion housing 280.

In some embodiments, the arm 281 a may be integral with the insertionhousing 280 and the arm 281 a may be sufficiently flexible tooperatively engage with and disengage from an engagement portion of thefirst member 202 as the arm 281 a flexes toward and away from the firstmember 202. In other embodiments, the arm 281 a may be operativelyconnected with the insertion housing 280. For example, the arm 281 a maybe adapted to pivot about a point 281 c to allow the arm 281 a tooperatively engage with and disengage from the first member 202 as thearm 281 pivots toward and away from the engagement portion of the firstmember 202. The engagement portion may be, but is not limited to, anaperture, a ridge, an undersurface (or upper surface), a protrusion, atab, an arm, a bias member, or any other suitable structure or mechanismarrangeable to allow the arm 281 to engage and/or disengage.

The insertion housing 280 may contain a main chamber 287 in alignmentwith the opening 240 b. The insertion housing 280 may have alongitudinal dimension and an insert structure 260 located within theinsertion housing 280. The insert structure 260 may be moveable alongthe longitudinal dimension in a direction L at least between a firstposition and a second position. The insert structure 260 may include afirst part 262 and a second part 264 operatively connected to the firstpart 262 so that the first part 262 and the second part 262 may movetogether along the longitudinal dimension of the insertion housing 280.The insert structure 260 may be biased toward or otherwise held in thefirst position until sufficient force is applied to the insert structure260 to move or otherwise actuate the insert structure 260 to the secondposition.

Various examples of suitable structures for insert structures aredescribed in U.S. patent application Ser. No. 11/645,435, filed Dec. 26,2006, entitled “Infusion Medium Delivery System, Device And Method WithNeedle Inserter And Needle Inserter Device And Method,” which isassigned to the assignee of the present invention and is incorporatedherein by reference in its entirety. Further examples of various insertstructures are described in, but are not limited to, U.S. patentapplication Ser. No. 11/645,972, filed Dec. 26, 2006, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method”; U.S. patent application Ser. No.11/646,052, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; U.S. patent application Ser. No. 11/645,435, filed Dec. 26,2006, “Infusion Medium Delivery System, Device And Method With NeedleInserter And Needle Inserter Device And Method”; U.S. patent applicationSer. No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method,” all of which are herein incorporated by reference inits entirety. Other examples of suitable structures for insertstructures are described herein.

The first part 262 of the insert structure 260 may include a plungerhead 288 and a needle 246 supported by the plunger head 288. The secondpart 264 of the insert structure 260 may include a collar 268 and acannula 248 supported by the collar 268. The plunger head 288 may beconnected to the collar 268. The first part 262 and the second part 264may be configured to be removably attachable from each other, forexample, in a friction fit engagement, snap fit engagement, or the like.For example, one of the plunger head 288 and the collar 268 may includeprotrusions or the like and the other of the plunger head 288 and thecollar 268 may include apertures for receiving the protrusions.

The cannula 248 may extend at least partially through the collar 268.The cannula 248 may be fixed to the collar 268 to move with movement ofthe insert structure 260. The cannula 248 may have a hollow centralchannel 248 c extending along a longitudinal length of the cannula 248and open at one end 248 a that may be adjacent a sharp end 246 a of theneedle 246 disposed within the cannula 248 as will be discussed. An end248 b of the cannula 248 opposite the open end 248 a may have a head 249having a larger radial dimension than a shaft portion 248 d of thecannula 248.

A septum 266 may be supported or otherwise retained by the collar 268.The septum 266 may be a resealable member made of silicone, plastic,rubber, or the like. The septum 266 may be arranged between the plungerhead 288 and the collar 268. The septum 266 may be pierceable by theneedle 246.

The needle 246 may be arranged to extend through at least a portion ofthe cannula 248. The needle 246 may be supported by, secured, oroperatively connected to the plunger head 288 to move with movement ofthe insert structure 260. Thus, in some embodiments, the plunger head288 and the needle 246, which may be both part of the first part 262 ofthe insert structure 260, and the collar 268 and the cannula 248, whichmay be both part of the second part 264 of the insert structure 260, maybe moveable at least between a first position and a second position.

In the second position, the needle 246 and the cannula 248 may extendthrough the opening 240 b of the channel 240 and at least partiallythrough the channel 240. As such, the sharp end 246 a of the needle 246and at least a portion of the length of the cannula 248 may extend outthe opening 240 a of the channel 240, for example, into skin of auser-patient.

The collar 268 of the insert structure 260 may have a suitable shape andsize to fit into the channel section 242 of the channel 240 when theinsert structure 260 is moved to the second position, for example, by anactuation device, as will be discussed later. In particular embodiments,the collar 268 may include one or more protrusions 267 and/orindentations that engage with one or more corresponding indentations,such as the aperture 205 a, and/or protrusions in the injection sitesection 205 to provide a friction fit, snap fit, or the like, to lock orretain the second part 264 within the injection site section 205 uponthe insert structure 260 being moved to the second position.

In further embodiments, instead of or in addition to engagingprotrusions and indentations, one or more other mechanical structuresmay be employed to provide a suitable retaining function for retainingthe second part 264 in place within the injection site section 205 uponthe insert structure 260 being moved to the second position, forexample, by an actuation device, including, but not limited to, afriction fit structure, snap fit structure, or the like.

In various embodiments, the arm 281 a of the insertion housing 280 maybe actuated to disengage the insertion housing 280 automatically fromthe first member 202 upon the insert structure 260 being moved to thesecond position. For example, the arm 281 a may be adapted to flex orpivot away from the insertion housing 280 to disengage the first member202 when the insert structure 260 is moved to the second position. Inmoving to the second position, one of the protrusions 267 may pushagainst the end 281 b of the arm 281 a located in the aperture 205 a.This may displace the end 281 b of the arm 281 and release the arm 281 aand/or the locking surface 281 d from the retaining surface 205 b fromthe first member 202. Accordingly, in such embodiments, the insertionhousing 280 may be removed. In some embodiments, removal of theinsertion housing 280 may also remove the first part 262 that mayinclude the needle 246 and the plunger 288, while leaving the secondpart 264 that may include the cannula 248 and the collar 268 engaged tothe injection site section 205.

The collar 268 may have a connection channel 269 provided in fluid flowcommunication with an opening (not shown) in the cannula 248 in fluidflow communication with the hollow central channel 248 c of the cannula248. Accordingly, the connection channel 269 may be in fluid flowcommunication with the hollow central channel 248 c of the cannula 248.The connection channel 269 may be provided along the collar 268 at alocation at which the connection channel 269 may align with the fluidconduit 224 when the insert structure 260 has been moved to the secondposition. Thus in some embodiments, in a case where the first member 202and the second member are brought together (e.g., FIG. 9) and the insertstructure 260 is in the second position, a fluid flow path may beestablished between the reservoir in the second member and the cannula248 via the fluid conduit 224 and the connection channel 269.

In some embodiments, the insertion housing 280 may include an innerhousing portion 284 concentrically arranged within an outer housingportion 281. The inner housing portion 284 may have an inner chamber 285in alignment with the chamber 287 in which the insert structure 260 maybe arranged for movement. A lip portion 284 a or the like extending fromthe inner housing portion 284 may be for containing the insert structure260 in the inner chamber 285. For example, the insert structure 260 maybe in contact with or otherwise adjacent the lip portion 284 a when theinsert structure 260 is in the first position.

The outer housing 281 may have an outer chamber 282 between the outerhousing 281 and the inner housing portion 284. The outer chamber 282 maybe for receiving at least a portion of an actuation device for actuatingthe plunger head 288 as will be described. In various embodiments, theinner housing portion 284 may be integral with the outer housing portion281. In other embodiments, the inner housing portion 284 may be separateand connected with the outer housing portion 281.

As previously discussed, in various embodiments, the insert structure260 (i.e., the plunger head 288, the needle 246, the collar 268, and thecannula 248) may be actuated to move to the second position by anactuation device 290. The actuation device 290 may include a housing 291securable to the insertion housing 280. A suitable connection structuremay be provided on the actuation device 290 and/or the insertion housing280 to provide a manually releasable connection between thosecomponents. In some embodiments, the connection structure may include,but is not limited to, a threaded extension on one or the other of theactuation device 290 and the insertion housing 280 and a correspondingthreaded receptacle on the other of the insertion housing 280 and theactuation device 290 for receiving the threaded extension in threadedengagement.

For example, an end 272 of a distal portion 270 of the actuation device290 may be adapted to be insertable into the insertion housing 280, forexample, within the outer chamber 282. The distal portion 270 may have athreaded portion 276 for threaded engagement of a threaded portion 282 awithin the insertion housing 280. The end 272 may be insertable into theouter chamber 282 of the insertion housing 280, for example, until asurface 271 of the actuation device 290 abuts a lip portion 283 of theinsertion housing 280 and/or the end 272 contacts a floor 284 b of theinsertion housing 280.

In other embodiments, other suitable connection structures may beemployed. Such a connection structure may include, but is not limitedto, friction-fitted sections of the insertion housing 280 and theactuation device 290, flexible pawls or extensions on one or the otherof the actuation device 290 and the insertion housing 280 and acorresponding aperture, stop surface, or the like on the other of theinsertion housing 280 and the actuation device 290.

The housing 291 may contain an internal chamber 292 having alongitudinal dimension and a member 298 arranged within the housing 291.The member 298 may be moveable in the direction L at least between afirst position (e.g., FIG. 19) and a second position. The housing 291may include a drive mechanism for actuating the member 298. The drivemechanism may be a bias member 293, such as, but not limited to, a coilspring, or the like, arranged within the internal chamber 292 of thehousing 291. The bias member 293 may be configured to impart a biasforce on the member 298 when the member 298 is in the first position tourge the member 298 toward the second position.

In some embodiments, an activation structure, such as a trigger, button,or the like, may be provided to control the actuation device 290. Infurther embodiments, a first trigger 294 may be configured to arm orprepare the actuation device 290 for firing or otherwise moving themember 298 to move the insert structure 260. For example, the firsttrigger 294 may be pressed to retract the member 298 to the firstposition. As such, the first trigger 294 may be adapted to selectivelyarm the member 298 and/or the bias member 293 into the first position(i.e., the retracted position).

A second trigger 297 or the like may be configured to selectivelyrelease the member 298 and/or the bias member 293 to allow the member298 to move in the direction L under the force of the bias member 293 tothe second position. In other embodiments, the first trigger 294 may beconfigured to selectively release the member 298 and/or the bias member293 to allow the member 298 to move in the direction L under the forceof the bias member 293 to the second position upon being operated afterthe actuation device 290 has been armed. For example, pressing the firsttrigger 294 a first time may retract the member 298 to the firstposition, and pressing the first trigger 294 a second time may releaseor otherwise allow the member 298 to advance to the second position.Other examples of insertion structures are described in U.S. Pat. Pub.No. US 2007/0142776, entitled “Insertion Device for an Insertion Set andMethod of Using the Same,” which is herein incorporated by reference inits entirety.

In yet further embodiments, a first locking mechanism (not shown) may beprovided such as, but not limited to, a manually moveable projection,lever, slider, or the like. The first locking mechanism may be connectedto or extending through the housing 291 and engaging the member 298 (orother structure holding the member 298) in a releasable manner toselectively hold the member 298 in the retracted position, for exampleafter the first trigger 294 has been operated, against the bias force ofthe bias member 293.

In some embodiments, the actuation device 290 may be configured to allowthe member 298 to be moved from the second position at least toward thefirst position automatically or upon manipulation by the user, forexample, to a third position or a neutral position (e.g., position ofthe member before being moved to the first position when the actuationdevice is armed). That is, after the member 298 has been moved to thesecond position (e.g., an extended position), the member 298 may bemoved to a third position automatically or upon manipulation of theactuation device 290 by the user-patient. The third position may be anysuitable position at which the needle 246 is sufficiently withdrawn, forexample, from the skin of the patient, as will be discussed, such as,but not limited to, the first position, a position between the first andsecond positions, or the like.

For example in some embodiments, the housing 291 may include a secondchamber 295. The second chamber 295 may be concentrically arrangedrelative to the internal chamber 292, for example around the internalchamber 292. A drive mechanism may be arranged within the second chamber295 of the housing 291 to move the member 298. The drive mechanism maybe a second bias member 296, such as, but not limited to, a coil spring,or the like, arranged to impart a bias force on the member 298 when themember 298 is in the second position to urge the member 298 toward thirdposition. Thus, in some embodiments, the member 298 can be moved to thefirst position (e.g., by pressing the first trigger 294), moved to thesecond position (e.g., by pressing the second trigger 297), and thenautomatically moved to a third position.

In some embodiments, an activation structure, such as a trigger (e.g.,first trigger 294, second trigger 297, or a third trigger (not shown)),button or the like, may be provided to control movement of the memberfrom the second position to the third position. Thus, in someembodiments, the member 298 can be moved to the first position (e.g., bypressing the first trigger 294), moved to the second position (e.g., bypressing the second trigger 297), and then further moved to a thirdposition (e.g., by pressing the first trigger 294, the second trigger297, or the like).

In yet further embodiments, a second locking mechanism (not shown) maybe provided such as, but not limited to, a manually moveable projection,lever, slider, or the like. The second locking mechanism may beconnected to or extending through the housing 291 and engaging themember 298 (or other structure holding the member 298) in a releasablemanner to selectively hold the member 298 in the second position, forexample after the second trigger 297 has been operated, against the biasforce of the second bias member 296.

In various embodiments, the member 298 may be adapted to operativelyengage the plunger head 288, for example, when the actuation device 290is connected to the insertion housing 280. The member 298 or a portionthereof may be made of a sufficiently rigid material, but having acertain amount of flexibility. A protrusion, extension, arm, or the likemay be provided on one or the other of the member 298 and the plunger288 and a corresponding aperture, protrusion, extension, arm or the likeon the other of the plunger 288 and the member 298 for engaging eachother. For example, in particular embodiments, the member 298 may haveone or more arms 299 for engaging a head portion 289 of the plunger head288 upon the actuation device 290 being connected to the insertionhousing 280.

Thus in some embodiments, in a case where the member 298 is operativelyengaged with the plunger head 288 and the member 298 is actuated, theinsert structure 260, which may include the plunger head 288, the needle246, the collar 268, and the cannula 248, may be moved to the secondposition. Similarly as previously described, the member 298 can befurther actuated to move the first part 262 of the insert structure 260,which may include the plunger head 288 and the needle 246, away from thefirst position (e.g., to (or toward) the first position and/or the thirdposition). Thus, the second part 464 of the insert structure 260, whichmay include the collar 268 and the cannula 248, may remain in the secondposition to allow fluid to flow from the reservoir though the fluidconduit 224 and the connection channel 269 to the cannula 248 into theuser-patient as previously described.

In various embodiments, the actuation device 290 may be configured forimproved handling of the actuation device 290 by the user-patient. Forexample, the actuation device 290 may include a handling portion 255,grips, textured surfaces, or the like that may aid in handling of theactuation device 290.

FIG. 21 illustrates a flowchart describing use of the system 200 (e.g.,FIGS. 17-20) according to an embodiment of the present invention. Withreference to FIGS. 17-21, the system 200 may be operated according toprocess 1000. In step S1010, the base 206 of the first member 202 may besecured to skin of a user-patient at a suitable injection location with,for example, but not limited to, adhesive material, or the like.Examples for securing the first member to the skin of the user-patientare described herein and can be found in U.S. patent application Ser.No. 11/645,435, filed Dec. 26, 2006, entitled “Infusion Medium Deliverysystem, Device And Method With Needle Inserter And Needle InserterDevice And Method” and U.S. patent application Ser. No. 12/027,963,filed Feb. 7, 2008, entitled “Adhesive Patch Systems and Methods,” allof which are herein incorporated by reference in their entirety.Alternatively or in addition, the base 206 may be secured to theuser-patient by one or more other suitable structures, including, butnot limited to, straps, or the like.

Once the base 206 is suitably secured the user-patient at a suitableinjection location, in step S1020, the insertion housing 280 may beaffixed to the inject site section 205. Then, in step S1030, theactuation device 290 may be connected to the insertion housing 280 tooperatively engage the member 298 with the plunger 288. Then in stepS1040, the actuation device 290 may be actuated, for example byactuating one or more of the first trigger 294 and the second trigger297, to move the member 298 to the second position.

In step S1042, the member 298 may move the insert structure 260, whichmay include the plunger 288, the needle 246, the collar 268, and thecannula 248, to the second position. As a result, in step S1044, theneedle 246 may pierce the skin of the user-patient allowing a portion ofthe cannula 248 to enter the user-patient. In step S1046, the insertstructure 260 may engage the inject site section 205 to retain thecannula 248 within the user-patient. The cannula 248 and collar 268 maybe retained in the second position by engagement of, for example, thecollar 268 and the injection site section 205, as previously described.As the insert structure 260 engages the inject site section 205, in stepS1048, the insert structure 260 may cause the insertion housing 280 todisengage from the first member 202.

Next in step S1050, with the cannula 248 and the body 268 locked in thesecond position, the actuation device 290 may be further actuated, forexample automatically or by operating one of the triggers, to causemovement of the member 298 to the third position. In step S1052, themember 298 may cause the first part 262 of the insert structure 260,which may include the plunger head 288 and the needle 246, to move awayfrom the second part 264 of the insert structure 260 (e.g., toward thefirst position). The second part 262 of the insert structure 260 mayremain in the inject site section 205 and the cannula 248 within theuser-patient. In step S1060, the second member may be attached to thefirst member 202 to provide a fluid flow path from the reservoir of thesecond member to the user-patient via the fluid conduit 224, theconnection channel 269 in the collar 268 of the insert structure 260,and the cannula 248. In other embodiments, such a flow path may be forconveying fluid from the user-patient to the reservoir.

A connection sequence (e.g., the sequence of connecting the actuationdevice 290 to the injection site section 205, connecting the firstmember 202 to the second member, attaching the base 206 of the firstmember 202 to the skin of the user-patient, etc.) for connecting variouscomponents may be different for different embodiments. For example, insome embodiments, the user-patient may be provided with a first member202 having a base 206, a housing 204, and an injection site section 205in a pre-connected state with the actuation device 290. In this manner,the user-patient need not have to connect the actuation device 290 tothe housing 204 as those parts are supplied to the user in apre-connected state, for example, from a manufacturing or assemblyfacility. In such embodiments, the base 206 of the first member 202 maybe secured to skin of the user-patient at a suitable injection location.After securing the base 206 to the skin of the user-patient, theactuation device 290 may be activated to cause the insert structure 260to move to the second position so that the needle 246 can pierce theskin of the user-patient.

While the connection sequence in some of the above embodiments involvesecuring the base 206 of the first member 202 to the user-patient priorto connection of the second member to the first member 202, in otherembodiments, the second member may be connected to the first member 202,as described above, prior to securing the base 206 of the first member202 onto the skin of the user-patient. In such embodiments, the firstmember 202 and the second member may be connected together and,thereafter, may be secured to the user-patient, for example, by adheringone or both of the first member 202 and the second member to the skin ofthe user-patient. In addition, while the connection sequence in theabove embodiments involve activating the actuation device 290 prior tothe connection of the second member to the first member 202, in otherembodiments, the second member may be connected to the first member 202,as described above, prior to activating the actuation device 290.

In some embodiments, the receptacle 210 may be in the first member 202and a connection portion may be in the second member. In otherembodiments, the receptacle 210 may be in the second member, forexample, in or associated with a housing for a reservoir, and theconnection portion may be in the first member 202, for example, in orassociated with a housing containing an injection site structure.

Returning to FIGS. 17-20, in some embodiments, the system 200 may beconfigured to detect that the cannula 248 is properly positioned, forexample, in the extended position or other desired position afteroperation by the actuation device 290.

In some embodiments, the insertion housing 280 may be provided with afirst interactive element 265. The injection site section 205 or otherportion of the first member 202 (e.g., the base 206) may be providedwith a second interactive element 207. The first interactive element 265and the second interactive element 207 may be configured to interactwith each other in a detectable manner when in sufficiently closeproximity to each other. As detailed in the disclosure, interactionbetween the various elements, such as (but not limited to) between thefirst interactive element 265 and the second interactive element 207,may include (but is not limited to) engaging of the elements, contactbetween the elements, application of a force (e.g., pressure) of oneelement on the other element, application of energy (e.g., electricalcharge, magnetic charge, heat, etc.), and/or any suitable exchangebetween the elements that is detectable. In other embodiments, theinsertion housing 280 may be provided with the second interactiveelement 207 and the injection site section 205 may be provided with thefirst interactive element 265. However, it should be noted that one orboth of the first interactive element 265 and the second interactiveelement 207 may be provided in any suitable component and/or along anysuitable location of the system 200. For example, the first interactiveelement 265 could be arranged in the actuation device 290. As anotherexample, the second interactive element 207 could be arranged on thebase 206 or component connected to the base 206. As a further example,both the first interactive element 265 and the second interactiveelement 207 could be arranged in the insertion housing 280.

The first interactive element 265 may be arranged in a fixed relation tothe insertion housing 280, for example, by attaching, forming, orotherwise supporting the first interactive element 265 to a suitablelocation on a wall or on other structure of or in the insertion housing280. In some embodiments, the first interactive element 265 may beprovided on the collar 268 or other portion of the insertion housing 280movable by the actuation device 290. The second interactive element 207may be arranged in a fixed relation to the second member 202, forexample, by attaching, forming, or otherwise supporting the secondinteractive element 207 to a suitable location on a wall or on otherstructure of or in the second member 202.

In some embodiments, the second interactive element 207 may be arrangedon the second member 202 to be relative to the first interactive element265 on the insertion housing 280 in a case where the insertion housing280 and the second member 202 are connected or otherwise operativelyengaged and the cannula 248 is properly positioned. Accordingly, thefirst interactive element 265 and the second interactive element 207 areproperly positioned (i.e., at expected locations) relative to eachother. As such, the first interactive element 265 and the secondinteractive element 207, for example, may interact with each other in acase where the insertion housing 280 and the second member 202 areconnected or otherwise operatively engaged and the first interactiveelement 265 and the second interactive element 207 are properlypositioned relative to each other.

An interaction between the first interactive element 265 and the secondinteractive element 207 (or between any other interactive elementdiscussed in the disclosure) may occur in a case where the cannula 248is positioned at a predefined position. The predefined position of thecannula 248, for example, may correspond to an extended position (e.g.,the extended position E of FIG. 16) of the cannula 248, for example,after being moved or otherwise actuated by the actuation device 290.Once the cannula 248 is the extended position, the cannula 248 may beconnected in fluid-flow communication with the reservoir of the secondmember 202 via the fluid conduit 224 and the connection channel 269. Insome embodiments, the predefined positioned of the cannula 248 may bewith respect to alignment in one or more dimensions (e.g., along the X-,Y-, and/or Z-axis).

In various embodiments, the first interactive element 265 and the secondinteractive element 207 may be similar types of devices. For instance,in some embodiments, the first interactive element 265 may be configuredto interact with second interactive elements (e.g., the secondinteractive element 207) and/or the second interactive element 207 maybe configured to interact with first interactive elements (e.g., thefirst interactive element 265).

In some embodiments, the first interactive element 265 and the secondinteractive element 207 may be dissimilar types of mechanisms. Forexample, the first interactive element 265 may be a ferrous conduit andthe second interactive element 207 may be a magnet.

In some embodiments, suitable electronics may be connected to the firstinteractive element 265 and/or second interactive element 207 to providea controlled power signal to selectively activate or otherwise controlone or more of the first interactive element 265 and the secondinteractive element 207 and/or other components as described throughoutthe disclosure.

In various embodiments, some or all of the interactive elements (e.g.,the first interactive element 265, the second interactive element 207)may be integrated with the insertion housing 280 and the second member202 and/or be separate components placed in or on the insertion housing280 and the second member 202. For example, the interactive elements maybe placed in or on the insertion housing 280 and the second member 202in a friction-fitting manner, during a molding a process, and/or thelike. In some embodiments, one or more of the interactive elements maybe insert mold labeled on its respective part. In some embodiments, afilm cover may be provided for supporting one or more of the interactiveelements.

In various embodiments, some or all of the interactive elements may havean exposed surface. The exposed surface of the interactive elements maybe for allowing increased interactivity between each of the interactiveelements. In other embodiments, some or all of the interactive elementsmay be covered, for example (but not limited to) being disposedcompletely within the insertion housing 280 and/or the second member202. Such embodiments may allow for protecting the interactive elementsfrom damage, debris collection, mitigating interference with othercomponents (e.g., other interactive elements, electronics in the system200, and/or the like), and/or the like.

Throughout various embodiments, the first interactive element 265 andthe second interactive element 207 may be configured to interact suchas, but not limited to, when the first interactive element 265 and thesecond interactive element 207 align in one dimension or more than onedimension, are sufficiently proximate to each other, contact each other,an electrical or magnetic connection is established between thecomponents, and/or the like. Any one or combination of these events mayoccur, for example, in a case where the cannula 248 is positioned in apredetermined manner otherwise within an operating threshold (e.g., inthe extended position).

In other embodiments, the first interactive element 265 may be arrangedon the insertion housing 280 at a location to interact electronically(or magnetically) with the second interactive element 207 in a casewhere the cannula 248 is extended and the first interactive element 265and the second interactive element 207 are in relative close proximityto each other, such as, but not limited to, in contact with each other.In some embodiments, suitable electronics may be connected to at leastone of the first interactive element 265 and the second interactiveelement 207 to provide a controlled power signal to selectively activateor otherwise control the first interactive element 265 and/or the secondinteractive element 207.

In some embodiments, one or more additional first interactive elementsand/or one or more additional second interactive elements may beprovided on the insertion housing 280 and the second member 202respectively, for example, to provide a more reliable detection of thecannula 248. For instance, a pair of second interactive elements 207 maybe arranged to face each other to detect a single first interactiveelement 265. As another example, a pair of second interactive elements207 may be arranged to interact with a respective first interactiveelement 265. In other embodiments, the one or more additional firstinteractive elements and/or the one or more additional secondinteractive elements may be arranged on different components than thosein which the first interactive element 265 and the second interactiveelement 207 are provided, respectively. Examples of such arrangementsare disclosed in (but are not limited to) U.S. application Ser. No.12/649,619, filed Dec. 29, 2009, which is herein incorporated byreference in its entirety.

Thus in various embodiments, as part of a process of placing a medicaldelivery device in fluid communication with a user, the user may place abase 206 of the medical delivery device adjacent skin of the user,attach a insertion housing 280 to the base 206, attach an actuationdevice 290 to the insertion housing 280, and actuate the actuationdevice 290 to extend a cannula 248 to an extended position to put theuser in fluid-flow communication with a reservoir of the medicaldelivery device. Accordingly, a first interactive element 265 and asecond interactive element 207 may interact with each other todetermine, for example, whether the 248 is properly positioned.

In some embodiments, the interactive elements (e.g., the firstinteractive element 265, the second interactive element 207) may beconfigured to help a user-patient properly position the cannula 248 orotherwise ensure that the cannula 248 is properly positioned. Forexample, the first interactive element 265 and the second interactiveelement 207 may be arranged at one or more appropriate locations on theinsertion housing 280 and the second member 202 (or other suitablecomponents) to allow an indicator or indicator device 420 (e.g., FIG.44) associated with the system 100 to provide an indication when thecannula 248 is properly positioned.

In some embodiments, a conductive medium 207 a may be at a positionadjacent one of the interactive elements, for example the secondinteractive element 207, or otherwise in communication with theinteractive elements to allow the conductive medium 207 a to function asa conductor for the interactive element. In such embodiments, theinteractive element may interact with the conductive medium 207 a toallow the conductive medium 207 a to be have similar characteristics orproperties, though not necessarily exactly the same characteristics orproperties, as the interactive element. For example, a magnetic secondinteractive element 207 may provide a magnetic charge to a magneticconductive medium 207 a. The conductive medium 207 a may be made of amaterial, such as, but not limited to, an electrically conductivematerial (e.g., metal, graphite, salt solutions, plasma, and/or thelike), a magnetically attractive material (e.g., metal), and/or thelike. In some embodiments, the conductive medium 207 a may be asufficiently high thermally conductive material (e.g., metal, or anyother material with a thermal conductivity, for example (but not limitedto), above 1), and/or the like.

In further embodiments, the conductive medium 207 a may be arranged onits respective part (e.g., the second member 202) to allow theinteractive element (e.g., the second interactive element 207) tointeract with the other interactive element (e.g., the first interactiveelement 265) on the opposing part (e.g., the insertion housing 280) viathe conductive medium 207 a in any of the manners described throughoutthe disclosure. For example, in particular embodiments, the firstinteractive element 265 may interact with the conductive medium 207 a ina case where the cannula 248 is positioned properly. Accordingly, thefirst interactive element 265 and the second interactive element 207 mayinteract with each other via the conductive medium 207 a. Thus, someembodiments may allow the first interactive element 265 to interact withthe conductive medium 207 a in addition to or alternative to the secondinteractive element 207. For example, a magnetic second interactiveelement 207 may magnetize a magnetically attractive conductive medium207 a, which may then interact with the first interactive element 265.

In some embodiments, the conductive medium 207 a may be arranged at aposition adjacent the other interactive element (e.g., the firstinteractive element 265) or otherwise in communication with the otherinteractive element to allow the conductive medium 207 a to function asa conductor for the other interactive element. In further embodiments,the conductive medium 207 a may be arranged on its respective part toallow the other interactive element to interact with the interactiveelement (e.g., the second interactive element 207) on the opposing partvia the conductive medium 207 a in any of the manners describedthroughout the disclosure. For example, in particular embodiments, thesecond interactive element 207 may interact with the conductive medium207 a in a case where the cannula 248 is properly positioned.Accordingly, the first interactive element 265 and the secondinteractive element 207 may interact with each other via the conductivemedium 207 a. Thus, some embodiments may allow for second interactiveelement 207 to interact with the conductive medium 207 a in addition toor alternative to the first interactive element 265. For example, anelectrical connection between the first interactive element 265 and thesecond interactive element 207 may be established upon the secondinteractive element 207 contacting the conductive medium 207 a (e.g.,electrically conductive medium).

In some embodiments, the indicator 420 may be configured to provide anindication corresponding to a type of position of the cannula 248, forexample, that the position of the cannula 248 is within a most preferredrange, an acceptable range (i.e., acceptable, but not most preferred),and/or the like. In some embodiments, the indicator may be configured toprovide an indication corresponding to various stages of movement of thecannula 248, for example, that the cannula 248 has not yet moved fromthe first position (e.g., as shown in FIG. 18), the cannula 248 hasmoved from the first position, but has not reached the extendedposition, the cannula 248 is at the extended position, the cannula 248has moved beyond the extended position, the cannula 248 is or is notmoving, and/or the like.

In various embodiments, one or more of the interactive elements (e.g.,the first interactive element 265, the second interactive element 207,and/or the like) may be a spring, finger, or other bias member forcontacting one or more of the other interactive elements upon thecannula 248 being moved to the extended position. In such embodiments,the one or more of the interactive elements may be made of a suitablyrigid material, such as, but not limited to, metal, plastic, glass,composite materials, rubber, and/or the like. Examples of suchconfigurations are disclosed in (but are not limited to) U.S.application Ser. No. 12/649,619, filed Dec. 29, 2009, which is hereinincorporated by reference in its entirety.

In various embodiments, more than one interactive element (e.g., thefirst interactive element 265, the second interactive element 207,and/or the like) may be spaced apart from each other on one of theinsertion housing 280 and the second member 202. At least one of themore than one interactive element (e.g., second interactive element 207)or a portion thereof may be movable by a portion (e.g., firstinteractive element 265, a finger, pusher, and/or the like) of the otherof the insertion housing 280 and the second member 202 upon the cannula248 being moved to the extended position. Examples of suchconfigurations are disclosed in (but are not limited to) U.S.application Ser. No. 12/649,619, filed Dec. 29, 2009, which is hereinincorporated by reference in its entirety.

In some embodiments, for example, the first interactive element 265 andthe second interactive element 207 can be arranged on one of theinsertion housing 280 and the second member 202 to be spaced apart andmovable relative to each other in a manner such as that previouslydescribed. In such embodiments, for instance, a portion of the other ofthe insertion housing 280 and the second member 202, such as a tab,finger, and/or the like, may be arranged to urge the first interactiveelement 265 and the second interactive element 207 toward each other toallow the interactive elements to interact (e.g., contact) with eachother. Thus in such embodiments, most or all of the interactive elementsmay be provided on one of the housing portions, for example in theinjection site section 205 of the second member 202, which may allow forreuse of the interactive elements. In other embodiments, the movableinteractive element may be any suitable intermediary member configuredto be movable relative to one or more of the interactive elements in amanner as described in the disclosure. Accordingly, movement of theintermediary member may allow for interaction (e.g., an electricalconnection) between the first interactive element 265 and the secondinteractive element 207.

In other embodiments, the movable interactive element (or a portionthereof) may instead be a flexible layer, such as a film made of asuitably flexible material including, but not limited to, a Mylar and/orthe like, that can be pushed upon by the portion of the opposing part tocontact the other interactive element. In further embodiments, theflexible layer may be a conductive layer, such an electricallyconductive medium (e.g., metal and/or the like), magnetically conductivemedium (e.g., a ferrous conduit), thermally conductive medium, and/orthe like.

In various embodiments, the interactive elements (e.g., the firstinteractive element 265, the second interactive element 207, and/or thelike) may allow for, but is not limited to, tracking a number of timesof use, a number of times a component has been connected to and/ordisconnected from other components, verifying proper connection and/oralignment of components in a medication delivery system prior to eachdelivery step, checking, sensing, and/or measuring parameters, such asambient parameters (e.g., ambient magnetic fields), operatingparameters, and/or the like, alerting users to conditions, such asconditions outside operating parameters of the delivery system, and/orthe like.

Various embodiments may employ different arrangements of interactiveelements on its respective components. For instance, in embodiments inwhich one of the components is intended to be disposable (e.g., disposedof after one or a prescribed number of uses or period of use), some ofthe interactive elements may be provided on the disposable part, whileother interactive elements may be provided on a durable part (i.e., notintended to be disposed). As a result, after a period of usage, theinteractive element(s) on the disposable part that may have attractedand collected stray material can be disposed of with the disposablepart.

On the other hand, the interactive element(s) on the durable part can besufficiently clean and free (or be cleaned) of stray material forfurther usage. In such embodiments, arranging at least some of theinteractive element(s) on the durable portion may provide certainadvantages, such as, but not limited to, being more cost-effective, forexample, by arranging interactive elements on respective parts based oncost; easier to manufacture and/or install, and/or the like. Forexample, electronics and circuitry (as discussed in the disclosure),such as, but not limited to, a sensor, a responsive device, and/or othercircuitry or electronics, may be arranged on the durable part.

In yet other embodiments, arranging at least some of the interactiveelement(s) on the disposable portion may provide certain advantages,such as, but not limited to, maintenance, cost, and/or the like. Forexample, such embodiments may allow for the interactive element(s) thathave worn down, been contaminated, or otherwise collected stray materialto be disposed of with the disposable part.

In some embodiments, at least one of the first interactive element 265and the second interactive element 207 may be a suitable sensor forsensing the other of the first interactive element 265, the secondinteractive element 207, or other element, such as the conductive medium207 a operatively connected to or otherwise associated with the other ofthe first interactive element 265 and the second interactive element207. Accordingly, upon the sensor detecting the presence of the other ofthe first interactive element 265 and second interactive element 207,the system may determine whether the cannula 248 has been properlypositioned. Such embodiments may be used in addition to or alternativelyof embodiments in which a first interactive element interacts with asecond interactive elements, for example, as described in thedisclosure.

In various embodiments, suitable electronics may be connected to thesensor and/or the other of the first interactive element 265 and thesecond interactive element 207 to provide a controlled power signal toselectively activate or otherwise control the sensor and/or the other ofthe first interactive element 265 and the second interactive element207. For example, the sensor may be controlled to activate uponconnecting to the actuation device 290, a manual activation of a controlbutton, switch, or other manual operator on one of the connectablecomponents or on a remote-controller device (not shown) connected inwireless communication with the sensor through suitable controlelectronics. As another example, the sensor may be controlled toactivate automatically after a certain action, such as activation of abutton, and/or the like or after a certain amount of time. In someembodiments, the sensor may be controlled to activate upon activation orinsertion of a particular component or device, such as, but not limitedto, connecting to the actuation device 290.

Examples of various needle insertion tools are described in thedisclosure and also in, but are not limited to, U.S. patent applicationSer. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; U.S. patent application Ser. No. 11/646,052, filedDec. 26, 2006, “Infusion Medium Delivery System, Device And Method WithNeedle Inserter And Needle Inserter Device And Method”; U.S. patentapplication Ser. No. 11/645,435, filed Dec. 26, 2006, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method”; U.S. patent application Ser. No.11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod,” all of which are herein incorporated by reference in theirentirety. Thus, in such examples, the sensor may be activated, forexample, before or after, the cannula 248 is extended so that adetermination can made whether the cannula 248 is properly positioned.

In some embodiments, the sensor may be activated upon interacting withthe other of the first interactive element 265 and the secondinteractive element 207. In some embodiments, an activating element,such as an activating magnet and/or the like, may be provided on atleast one of the insertion housing 280 and the second member 202. Theactivating element may activate the sensor upon interacting with eachother, for example by contacting each other as the cannula 248 isextended. In particular embodiments, the activating element may be oneof the interactive elements.

The sensor may be any suitable detector configured to detect adetectable feature, such as an interactive element (e.g., the firstinteractive element 265, the second interactive element 207, and/or thelike) or a presence of an interactive element, such as a magnetic field,electric field, and/or the like provided by the interactive element. Infurther embodiments, the sensor may be configured to and/or associatedwith electronics configured to produce an electronically detectablestate or signal upon detecting the detectable feature. For example, thesensor may be a sensor pad and/or the like configured to sense, detect,and/or otherwise interact with an interactive element upon theinteractive element being in sufficient proximity (e.g., in contact)with the sensor pad. In certain embodiments, the sensor may include aconventional activating switch or a conventional device capable ofdetecting a particular detectable feature such as an interactive element(e.g., the first interactive element 265, the second interactive element207, and/or the like) or a presence of an interactive element, such as amagnetic field, electric field, and/or the like provided by theinteractive element.

In some embodiments, the sensor may be configured to sense, detect, ormeasure a presence of the interactive element. For example, suchembodiments may allow for the sensor to sense a presence (e.g., amagnetic field) of the interactive element rather than the elementitself. In particular, the sensor may be configured to sense, detect, ormeasure, but is not limited to, magnetic fields; electric fields;temperature or heat; optical and/or visual features (e.g., barcodes,colors, grayscale, and/or the like); tactile features; audio features;radio frequencies (RF) or other radio signals; ultraviolet light, orother light; force; torque; resistances (e.g., coded resistancepattern); capacitances; inductances; ultrasonic signals, and/or thelike; and/or the like provided by, emitted from, produced by, orotherwise present in an interactive element.

For example, the sensor may be configured to sense a magnetic fieldemitted by a magnetic first interactive element 265 to determine whetherthe cannula 248 is properly positioned. If the sensor fails to detectthe magnetic field provided by the magnetic first interactive element265, then this may indicate that the cannula 248 is not properlypositioned. On the contrary, if the sensor detects the magnetic fieldprovided by the magnetic first interactive element 265, then this mayindicate that the cannula 248 is properly positioned (e.g., the cannula248 is extended to a location within a certain tolerance).

In further embodiments, the sensor may be configured to measure a valueor presence parameter, magnitudes, changes, gradients, polarities,vectors, field directions, and/or any other measurable parametersuitable for detecting and/or measuring a detectable feature. Forexample, the sensor may be configured to measure a gauss level of amagnetic field provided by the first interactive element 265.

In various embodiments, the detectable feature (e.g., the firstinteractive element 265) may be selected, configured, and/or arranged toprovide a particular detectability (i.e., a characteristic or traitcapable of being detected) such that, for example, the interactiveelement and/or the presence of the interactive element may be sensed bythe sensor only when the first cannula 248 is properly positioned. Forinstance, a magnetic first interactive element 265 may be selected toprovide a magnetic field having a particular gauss level that may bedetectable by the sensor only if the sensor is sufficiently locatedrelative to the magnetic first interactive element 265, which wouldoccur, for example, if the cannula 248 is properly positioned.

Alternatively or in addition, the sensor may be selected, configured,and/or arranged to provide a sensitivity or otherwise control an amountsensed of the detectable feature by the sensor. Thus, for instance, theinteractive element and/or the presence of the interactive element maybe sensed by the sensor only when the cannula 248 is properlypositioned; otherwise, the detectable feature would not be sufficientlyproximate to the sensor to be detectable by the sensor. For instance, asensor may be configured to sense, for example, a first interactiveelement 265 or field thereof only if sufficiently proximate to themagnetic first interactive element 265.

Such embodiments may allow, for example, for a lesser tolerance inpositioning the cannula 248. Accordingly, such embodiments may be usedin a case where positioning of the cannula 248 needs (but not limitedto) more precision. In other embodiments, the sensor may have anincreased sensitivity or the like. Such embodiments may allow, forexample, for a greater tolerance in positioning the cannula 248.

In some embodiments, the sensor or other associated circuitry may beconfigured such that a detection not meeting a certain range (e.g.,below the range or above the range) or threshold may be ignored orotherwise determined to be unacceptable by the sensor (or otherassociated circuitry). Thus, in such embodiments, a case where thesensor does not detect the interactive element and/or the presence ofthe interactive element, the sensor (or other circuitry) may provide anindication that the cannula 248 is not properly positioned.

In yet further embodiments, the sensor and/or other associatedelectronics may be configured such that a detection not meeting acertain range or threshold (i.e., determined to be unacceptable) mayprovide an indication that the detection does not meet the certain rangeor threshold. For example, such an indication may indicate that thecannula 248 has been extended, but has not reached the proper depth orposition.

In some embodiments, other interactive elements or structures may beprovided to regulate the sensing and/or measuring ability of the sensorand/or the detectability and/or measurability of the detectable feature.For instance, a heat-emitting first interactive element 265 may be atleast partially surrounded by a low thermally conductive material, suchas plastic, rubber, wood, and/or the like. This may allow a heat-sensingsensor to sense the heat-emitting first interactive element 265 and/or asuitable presence thereof only when the cannula 248 is properlypositioned, thus substantially preventing a false detection of heat thatmay be emitted, for example, laterally from the heat-emitting firstinteractive element 265.

In various embodiments, one of the interactive elements may have acapacitance that is measurable. Another interactive element (or othercomponent) may be configured to affect the capacitance of the one of theinteractive elements, for example, by being brought in proximity orcontact with the one of the interactive elements. The affectedcapacitance of the one of the interactive elements may be measured orotherwise detected by the sensor to indicate a change in state, forexample, when the cannula 248 is properly positioned.

In various embodiments, one of the interactive elements may have aninductance that is measurable. Another interactive element (or othercomponent) may be configured to affect the inductance of the one of theinteractive elements, for example, by being brought in proximity orcontact with the one of the interactive elements. The affectedinductance of the one of the interactive elements may be measured orotherwise detected by the sensor to indicate a change in state, forexample, when the cannula 248 is properly positioned.

In some embodiments, one or more additional sensors interactive elementsmay be provided on the insertion housing 280 and the second member 202respectively, for example, to provide a more reliable detection of thecannula 248. For instance, a pair of sensors may be arranged to faceeach other to detect a single first interactive element 265. As anotherexample, a pair of sensors may be arranged to interact with a respectivefirst interactive element 265. In other embodiments, the one or moreadditional sensors may be arranged on different components than those inwhich the first interactive element 265 and the second interactiveelement 207 are provided, respectively. Examples of such arrangementsare disclosed in (but are not limited to) U.S. application Ser. No.12/649,619, filed Dec. 29, 2009, which is herein incorporated byreference in its entirety.

In some embodiments, both the first interactive element 265 and thesecond interactive element 207 may each be a sensor. In suchembodiments, the one or more of the sensors may be configured to detectthe other sensor and/or other interactive element(s). For example, thecannula 248 may be determined to have been positioned properly in a casewhere (but not limited to) one of the sensors detects the other sensor,the sensors both detect each other, at least one of the sensors detectsan interactive element, the sensors both detect a same (or different)interactive element, and/or the like.

In further embodiments, further sensors may be provided for detectingother sensors (and/or interactive elements). In such embodiments, thecannula 248 may be determined to have been positioned properly, but isnot limited to, upon one or more or a predetermined amount of thesensors detecting a particular or any of the other sensors, the sensorsdetecting each other, at least one of the sensors detecting an otherinteractive element, the sensors detecting a same (or different)interactive element and/or the like.

In various embodiments, one or more additional sensing structures, suchas those described in the disclosure, may be provided to properlyposition the cannula 248, for example, to increase reliability ofcannula 248 positioning and/or decrease time for sensing properpositioning of the cannula 248.

Thus in various embodiments, as part of a process of placing a medicaldelivery device in fluid communication with a user, the user may place abase 206 of the medical delivery device adjacent skin of the user,attach a insertion housing 280 to the base 206, attach an actuationdevice 290 to the insertion housing 280, and actuate the actuationdevice 290 to extend a cannula 248 to an extended position to put theuser in fluid-flow communication with a reservoir of the medicaldelivery device. Accordingly, a sensor (e.g., second interactive element207) may detect a detectable feature (e.g., first interactive element265) to determine, for example, whether the cannula 248 is properlypositioned.

Further examples of arrangements of sensors for detecting detectablefeatures (e.g., interactive elements, conductive medium, etc.) or thelike are disclosed in (but are not limited to) U.S. application Ser. No.12/649,619, filed Dec. 29, 2009, which is herein incorporated byreference in its entirety.

In various embodiments, the interactive element(s) (e.g., firstinteractive element 265, second interactive element 207, conductivemedium 207 a, sensors) and the like need not be used or otherwiselimited to two housing portions. Examples of interactive elementsarranged among three or more housing portions are disclosed in (but arenot limited to) U.S. application Ser. No. 12/649,619, filed Dec. 29,2009, which is herein incorporated by reference in its entirety.

Thus various embodiments may allow for verification of multiple distinctand separate components or steps, verification of correct positioning ofmultiple distinct and separate components, a safety mechanism to providenotification of separation (intentional or accidental) of any individualcomponent in a multi-component system, and/or the like. For instance, aninteractive element positioned in each of the actuation device 290, theinsertion housing 280, and the second member 202 may allow for adetermination that the actuation device 290 has been properly connectedto the insertion housing 280 and a determination that the cannula 248has been properly positioned upon actuation of the actuation device 290.

In various embodiments, the system may include at least one responsivedevice (not shown) configured to provide an electronically detectablestate or signal in response to an interaction (or lack thereof) betweentwo or more interactive elements (e.g., the first interactive element265, the second interactive element 207, the conductive medium 207 a,the sensor, etc.). Thus, in some embodiments, a responsive device may beconfigured to provide a signal in a case where the cannula 248 isproperly positioned. The signal may indicate, for example, the two ormore interactive elements have interacted, and thus the cannula 248 isproperly positioned. Examples of configurations using at least oneresponsive device are disclosed in (but not limited to) U.S. applicationSer. No. 12/649,619, filed Dec. 29, 2009, which is herein incorporatedby reference in its entirety. Thus, for instance, the responsive device.

In various embodiments, the responsive device, the sensor, and/or otherinteractive element(s) may be connected in electrical communication withcontrol electronics (not shown). The control electronics may beincorporated within the control electronics for controlling a drivedevice 44 (e.g., FIG. 4) such as, but not limited to, the controlelectronics 52 (e.g., FIG. 4) for controlling the drive device 44.Alternatively, the control electronics may be separate from and inaddition to the control electronics 52, but connected in electricalcommunication with the control electronics 52 and/or the drive device 44to provide a drive control signal to the drive device 44. Morespecifically, the control electronics may be configured to inhibitoperation of the drive device 44, unless the responsive device (or thelike) provides a signal or a change in state to the control electronics.For instance, as previously discussed, the responsive device 410 mayprovide such a signal or a change in state upon being activated by aninteractive element, for example, when the cannula 248 is properlypositioned. In other words, the drive device 44 may be inoperable unlessthe cannula 248 is properly positioned.

In particular embodiments, the control electronics may include a wake-upfunction that allows the drive device 44 (or other component) to remainin a first mode (e.g., low-power mode) until the responsive device (orthe like) provides a signal or a change in state to the controlelectronics, for example, upon proper positioning of the cannula 248.Upon providing the signal or the change in state to the controlelectronics, the drive device 44 (or other component) may switch fromthe first mode to a second mode.

In some embodiments, the control electronics may provide a detect signalsuch as, but not limited to an electronic signal, flag setting, or otherindicator to the control electronics 52 and/or the drive device 44 uponactivation of the responsive device (or the like) by an interactiveelement. In such embodiments, the control electronics 52 and/or thedrive device 44 may be configured to allow operation of the drive device44 only upon the presence of the detect signal.

In further embodiments, in which multiple responsive devices (and/or thelike) are used, the control electronics may be configured to provide adetect signal, for example, to allow operation of the drive device 44only upon an activation of all or a predefined number or set of theresponsive devices (and/or the like). In yet further embodiments, thecontrol electronics may be configured to provide a detect signal, forexample, to allow operation of the drive device 44 only upon anactivation of all or a predefined number or set of the responsivedevices (and/or the like) in a particular order. Such embodiments mayallow, for example, for connection of components in a particularsequence, orientation, and/or in a particular direction, as well asperformance of steps in a particular sequence, and/or the like.

The control electronics and/or the control electronics 52 (e.g., FIG. 4)may be configured to control the drive device 44 (e.g., FIG. 4) invarious manners in accordance with various embodiments of the invention.For instance, the drive device may be controlled to prevent pumping(delivery) operation unless the cannula 248 is properly positioned. Orfor instance, the drive device 44 may be controlled to stop pumping(delivery) operation upon a detection of an interruption of a fluid-flowpath or a disconnection of a critical component, for example, if thecannula 248 is dislodged from the proper position.

In alternative or in addition, the control electronics and/or thecontrol electronics 52 (e.g., FIG. 4) may be configured to detect afirst-time proper positioning of the cannula 248 or other first-timeaction, as compared to a re-positioning of the cannula 248 afterprevious or partial usage. In this manner, the drive device 44 may becontrolled to provide a priming operation or other suitable first-timeoperation(s) upon detection of a first-time proper positioning. Asanother example, the drive device 44 may be controlled to prevent adelivery even if the cannula 248 is properly positioned if it has beendetermined that the cannula 248 has moved out of the proper position(e.g., outside the skin of the user-patient) and back to the properposition.

In yet further embodiments, the system may include additional sensors,responsive devices, and/or the like connected for electricalcommunication with the control electronics. Such additional sensors,responsive devices, and/or the like may comprise magnetically and/orelectronically actuating switches, magnetic and/or electric fieldmagnitude and direction sensors, inductive sensors, other proximitysensors, contact sensors, and/or the like for providing a detectablesignal or change in a state upon properly positioning the cannula 248 orupon predetermined action. Such predetermined actions may comprise, forexample, one or more of a proper connection of a reservoir into ahousing portion or base, a proper connection of a conduit to areservoir, a proper connection of two conduits together, a propersetting of a needle or cannula in an inserted state, a proper connectionof a conduit to a cannula or needle, or a proper connection of othercomponents of or to the system.

Alternatively, or in addition, the additional sensors, responsivedevices, and/or the like may include or be one or more flow detectorsfor detecting the occurrence or blockage of a fluid flow path in thesystem. In such embodiments, the control electronics may be configuredto provide a detect signal, for example, to allow operation of the drivedevice 44 only upon an activation of all or a predefined number or setof additional sensors, responsive devices, and/or the like or a properstate of the additional sensors, responsive devices, and/or the like.

In various embodiments, the system 200 is configured to determinewhether the cannula 248 is properly positioned, for example, upon thecannula 248 being moved to the extended position by the actuation device290. In further embodiments, the system 200 is configured to determinewhether the cannula 248 is properly positioned each time a pump commandis issued by the drive device 44 (or the like). Thus, for example, ifthe cannula 248 is not in position, the pump command is not issued or anissued pump command is not carried out.

In some embodiments, the control electronics 414 and/or the controlelectronics 52 (e.g., FIG. 4) may be configured to provide auser-perceptible indication of a proper positioning of the cannula 248or other action, such as connecting the actuation device 290 to theinsertion housing 280. For example, upon detection of a properpositioning of the cannula 248, the control electronics (or the controlelectronics 52) may provide a suitable control signal to activate anindicator device 420, as shown in FIG. 44.

The indicator device 420 may operated by a processor 422. The processor422 may be configured to execute various programs and/or to processvarious information, such as data received from one or more sensors,responsive devices, and/or other interactive elements. The processor422, for example, may be configured to compare detected signals withthresholds and/or pre-stored values in memory 424.

With reference to FIGS. 18-20 and 44, the indicator device 420 mayinclude, but is not limited to, an audible indicator, an opticalindicator, a tactile indicator, combinations of one or more thoseindicators, and/or the like. For example, upon positioning of thecannula 248 or other predetermined action as described above, an audiblebeeping sound or other suitable sound may be generated by a soundgenerating device in or associated the system. For example, uponproperly positioning the cannula 248, a flashing light or other suitablevisual indicator may be generated by an LED or other light source or adisplay device on or associated with the system. For example, uponproperly positioning the cannula 248, a vibration and/or the like may begenerated by a vibration device and/or the like in or associated withthe system.

In some embodiments, one or more signals may be communicated from atransmitter (not shown) in the system to a remotely locatedcommunication device (not shown), such as, but not limited to, ahand-held controller, a computer, and/or the like. Accordingly, thetransmitter may provide one or more of the above-noted user-perceptibleindications to a user of the communication device. In some embodiments,a text or graphic message may be displayed on a display screen on thesystem and/or on the communication device as an indicator of a properpositioning of the cannula 248.

In various embodiments, the system 200 is configured to determinewhether the cannula 248 is properly positioned, for example, in theextended position after operation by the actuation device 290 or otherdesired position. However, in other embodiments, the system 200 may beconfigured to determine (but is not limited to) whether the cannula 248is at another position, such as the starting position (e.g., shown inFIG. 18), somewhere between the starting position and the extendedposition, or the like. In other embodiments, the system 200 may beconfigured to determine whether another component is properlypositioned. For example, the system may be configured to determine (butis not limited to) whether the actuation device 290 is properlyconnected to the insertion housing 280, the insertion housing 280 isproperly connected to the second member 202. In particular embodiments,the system 200 may be configured to determine whether a particular fluidconnector is positioned properly (e.g., one that would allow forfluid-flow without leaking, exposure to contaminants, or the like). Forexample, the system 200 may be configured to determine whether theneedle 124 (FIG. 8) is properly positioned in the reservoir housing 108(FIG. 8) when the first member 102 (FIG. 8) is brought together with thesecond member 103 (FIG. 8).

In various embodiments, the system 200 may be configured to provideinformation relating to one or more of the interactive elements. Forinstance, in some embodiments, the detectable feature (or otherinteractive element) may include data, information, or the like thatwhen detected by or otherwise interacting with the sensor (or otherinteract element), the sensor may detect the data. For example, a firstcannula having a first length may provide first data and a secondcannula having a second length (different from the first length) mayprovide second data. Accordingly, the sensor can detect whether thesystem 200 is using the first cannula or the second cannula based on thedata the sensor detects.

In further embodiments, the system 200 may be configured to perform anaction based on the detected data. For example, if the sensor detectsthe first cannula, the first cannula is properly positioned when thefirst cannula is positioned at a first location. If the sensor detectsthe second cannula, the second cannula is properly positioned when thesecond cannula is positioned at a second location different from thefirst location.

Thus in various embodiments, the system 200 may be configured todetermine a type and/or characteristics of a cannula (or otherappropriate component) being used. In such embodiments, for example, thesystem 200 may be configured to determine a length (and/or otherdimension) of the cannula, material of the cannula, and/or the like.

FIGS. 22 and 23 illustrate an actuation device 390 according to anembodiment of the present invention. FIG. 24 illustrates a process forusing the actuation device 390. Although the actuation device 390 may besimilar or used with the embodiments of FIGS. 17-21, it should beunderstood that the actuation device 390 may also include some or all ofthe same components and operate in a manner similar to that shown anddescribed in the embodiments of FIGS. 1-16. In addition, some or all ofthe features shown in FIGS. 1-21 may be combined in various ways andincluded in the embodiments and process shown in FIGS. 22-24. Likewise,it should be understood that any of the features of the embodiments andprocess of FIGS. 22-24 may be combined or otherwise incorporated intoany of the other embodiments and process of FIGS. 22-24 as well as anyother embodiment herein discussed.

The actuation device 390 may be similar to the actuation device 290(e.g., FIGS. 17-20). With reference to FIGS. 17-23, the actuation device390 may include a housing 391 securable to the insertion housing 280. Asuitable connection structure may be provided on the actuation device390 and/or the insertion housing 280 to provide a manually releasableconnection between those components. For example, the connectionstructure may be similar to the connection structure previouslydescribed for connecting the actuation device 290 to the insertionhousing 280. In some embodiments, the connection structure may include,but is not limited to, a threaded extension on one or the other of theactuation device 390 and the insertion housing 280 and a correspondingthreaded receptacle on the other of the insertion housing 280 and theactuation device 390 for receiving the threaded extension in threadedengagement.

For example, an end 372 of a distal portion 370 of the actuation device390 may be adapted to be insertable into the insertion housing 280, forexample, within the outer chamber 282. The distal portion 370 may have athreaded portion 376 for threaded engagement of a threaded portion 282 awithin the insertion housing 280. The end 372 may be insertable into theouter chamber 282 of the insertion housing 280, for example, until asurface 371 of the actuation device 390 abuts a lip portion 283 of theinsertion housing 280 and/or the end 372 contacts a floor 284 b of theinsertion housing 280.

In other embodiments, other suitable connection structures may beemployed. Such a connection structure may include, but is not limitedto, flexible pawls or extensions on one or the other of the actuationdevice 390 and the insertion housing 280 and a corresponding aperture,stop surface, or the like on the other of the insertion housing 280 andthe actuation device 390.

The housing 391 may contain an internal chamber 392 having alongitudinal dimension and a member 398 arranged within the housing 391.The member 398 may be moveable in the direction L at least between afirst position and a second position. The housing 391 may include adrive mechanism for actuating the member 398. The drive mechanism may bea bias member 393, such as, but not limited to, a coil spring, or thelike, arranged within the internal chamber 392 of the housing 391. Thebias member 393 may be configured to impart a bias force on the member398 when the member 398 is in the first position to urge the member 398toward the second position.

In some embodiments, an activation structure, such as a trigger, button,or the like, may be provided to control the actuation device 390. Infurther embodiments, a first trigger 394 may be configured to arm orprepare the actuation device 390 for firing or otherwise moving themember 398 to move the insert structure 260. For example, the firsttrigger 394 may be manually pressed to retract the bias member 393 tothe first position. As such, the first button 394 may be adapted toselectively arm the member 398 and/or the bias member 393 into the firstposition (i.e., the retracted position).

A second trigger 397 or the like may be configured to selectivelyrelease the member 398 and/or the bias member 393 to allow the member398 to move in the direction L under the force of the bias member 393 tothe second position. In other embodiments, the first trigger 394 may beconfigured to selectively release the member 398 and/or the bias member393 to allow the member 398 to move in the direction L under the forceof the bias member 393 to the second position upon being operated afterthe actuation device 390 has been armed. For example, pressing the firsttrigger 394 a first time may retract the member 398 to the firstposition, and pressing the first trigger 394 a second time may releaseor otherwise allow the member 398 to advance to the second position.Other examples of insertion structures are described in U.S. Pat. Pub.No. US 2007/0142776, entitled “Insertion Device for an Insertion Set andMethod of Using the Same,” which is herein incorporated by reference inits entirety.

In yet further embodiments, a first locking mechanism (not shown) may beprovided such as, but not limited to, a manually moveable projection,lever, slider, or the like. The first locking mechanism may be connectedto or extending through the housing 391 and engaging the member 398 (orother structure holding the member 398) in a releasable manner toselectively hold the member 398 in the retracted position, for exampleafter the first trigger 394 has been operated, against the bias force ofthe bias member 393.

In some embodiments, the actuation device 390 may be configured to allowthe member 398 to be moved from the second position at least toward thefirst position automatically or upon manipulation by the user, forexample, to a third position or a neutral position (e.g., position ofthe member before being moved to the first position when the actuationdevice is armed). That is, after the member 398 has been moved to thesecond position (e.g., an extended position), the member 398 may bemoved to a third position automatically or upon manipulation of theactuation device 390 by the user-patient. The third position may be anysuitable position at which the needle 246 is sufficiently withdrawn, forexample, from the skin of the patient, such as, but not limited to, thefirst position, a position between the first and second positions, orthe like.

For example in some embodiments, the housing 391 may include a secondchamber 395. The second chamber 395 may be concentrically arrangedrelative to the internal chamber 392, for example around the internalchamber 392. A drive mechanism may be arranged within the second chamber395 of the housing 391 to move the member 398. The drive mechanism maybe a second bias member 396, such as, but not limited to, a coil spring,or the like, arranged to impart a bias force on the member 398 when themember 398 is in the second position to urge the member 398 toward thirdposition. Thus, in some embodiments, the member 398 can be moved to thefirst position (e.g., by pressing the first trigger 394), moved to thesecond position (e.g., by pressing the second trigger 397), and thenautomatically moved to a third position.

In some embodiments, an activation structure, such as a trigger (e.g.,first trigger 394, second trigger 397, or a third or further trigger(not shown)), button or the like, may be provided to control movement ofthe member from the second position to the third position. Thus, in someembodiments, the member 398 can be moved to the first position (e.g., bypressing the first trigger 394), moved to the second position (e.g., bypressing the second trigger 397), and then further moved to a thirdposition (e.g., by pressing the first trigger 394, the second trigger397, or the like).

In yet further embodiments, a second locking mechanism (not shown) maybe provided such as, but not limited to, a manually moveable projection,lever, slider, or the like. The second locking mechanism may beconnected to or extending through the housing 391 and engaging themember 398 (or other structure holding the member 298) in a releasablemanner to selectively hold the member 398 in the second position, forexample after the second trigger 397 has been operated, against the biasforce of the second bias member 396.

In various embodiments, the member 398 may be adapted to operativelyengage the plunger head 288, for example, when the actuation device 390is connected to the insertion housing 280. The member 398 or a portionthereof may be made of a sufficiently rigid material, but having acertain amount of flexibility. A protrusion, extension, arm, or the likemay be provided on one or the other of the member 398 and the plunger288 and a corresponding aperture, protrusion, extension, arm or the likeon the other of the plunger 288 and the member 398 for engaging eachother. For example, in particular embodiments, the member 398 may haveone or more arms 399 for engaging a head portion 289 of the plunger head288 upon the actuation device 390 being connected to the insertionhousing 280.

Thus in some embodiments, in a case where the member 398 is operativelyengaged with the plunger head 288 and the member 398 is actuated, theinsert structure 260, which may include the plunger head 288, the needle246, the collar 268, and the cannula 248, may be moved to the secondposition. Similarly as previously described, the member 398 can befurther actuated to move the first part 262 of the insert structure 260,which may include the plunger head 288 and the needle 246, away from thefirst position (e.g., to (or toward) the first position and/or the thirdposition). Thus, the second part of the insert structure 260, which mayinclude the collar 268 and the cannula 248, may remain in the secondposition to allow fluid to flow from the reservoir though the fluidconduit 224 and the connection channel 269 to the cannula 248 into theuser-patient as previously described.

In various embodiments, the actuation device 390 may be configured forimproved handling of the actuation device 390 by the user-patient. Forexample, the actuation device 390 may include a handling portion 355,grips, textured surfaces, or the like that may aid in handling of theactuation device 390.

Additionally, the actuation device 390 may allow for lancing or piercingthe skin of the user-patient, for example, to obtain a blood sample. Alancing portion 350 may be removably attachable to the actuation device390. The lancing portion 350 may be attached to or within the distalportion 370 in a friction fit, snap fit, threaded engagement, or thelike. The lancing portion 350 may be adapted to operatively engage themember 398 such that movement of the member 398 causes movement of thelancing portion 350.

In various embodiments, the lancing portion 350 may be adapted to beremovably attachable from the actuation device 390. For instance, whenthe lancing portion 350 is not in use, for example, the actuation device390 may be coupled with an insertion housing (e.g., 280 in FIGS. 17-20)for inserting a needle and a cannula into the skin of the user-patientas previously described. Moreover, when the actuation device 390 is notbeing used with the insertion housing, the lancing portion 350 may beattached to the actuation device 390 for piercing the skin of theuser-patient. The lancing portion 350 may be made of a material ofsuitable strength and durability such as, but not limited to, plastic,metal, glass, or the like.

The lancing portion 350 may include a collar body 352 and a piercingmember, such as a needle 354. The collar body 352 may be made of amaterial of suitable strength and durability such as, but not limitedto, plastic, metal, glass, or the like. The needle 354 may be supportedby the collar body 352 so that the needle 354 may move with the collarbody 352. For example, the needle 354 may extend through the collar body352 or be operatively connected to the collar body 352. As previouslydiscussed, in a case where the lancing portion 350 is operativelyengaged with the member 398 and the member 398 is actuated, the lancingportion 350 may be caused to move by the member 398. Accordingly, theneedle 354 may be actuated to move and exit the actuation device 390 to“prick” or otherwise pierce the skin of the user-patient. In otherembodiments, the piercing member (e.g., needle 354) may be connected tothe member 398 such that movement of the member 398 causes movement ofthe piercing member.

In various embodiments, a penetration depth of the needle 354 into theskin of the user-patient may be adjustable. In some embodiments, thelancing portion 350 may be adapted to be arranged relative to theactuation device 390 to adjust the penetration depth of the needle 354.For example, by inserting the lancing portion 350 further into orfurther along the actuation device 390, the penetration depth of theneedle 354 can be reduced accordingly. Conversely, the penetration depthof the needle 354 can be increased by arranging or otherwise extendingthe lancing portion 350 further from the actuation device 390. In someembodiments, the needle 354 may be adapted to be adjustable relative tothe collar body 352 in a similar fashion to decrease or increase thepenetration depth of the needle 354.

In some embodiments, the actuation device 390 may include an adjustmentmember (not shown) for selectively adjusting the penetration depth ofthe needle 354. The adjustment member may be an at least partiallyrotatable dial, a slide, a trigger, a button, or the like. Theadjustment member may be operatively engaged with the member 398, thefirst bias member 393, the second bias member 396, the collar body 352of the lancing portion 350, and/or the needle 354 so that thepenetration depth of the needle 354 can be varied. For example, rotationof the adjustment member may cause the lancing portion 350, portionthereof, and/or operatively connected components to advance or retreatrelative to the actuation device 390 to increase or decrease thepenetration depth of the needle 354.

In some embodiments, the actuation device 390 may be adapted to engagewith and disengage from a guard 330 or cover. The guard 330 may have ahousing 332 having an interior chamber 334. The guard 330 may be made ofa material of suitable strength and durability such as, but not limitedto, plastic, metal, glass, or the like. A suitable connection structure,such as one of the connection structures previously described, may beprovided on the actuation device 390 and/or the guard 330 to provide amanually releasable connection between those components. In someembodiments, the connection structure may include, but is not limitedto, a threaded extension on one or the other of the actuation device 390and the guard 330 and a corresponding threaded receptacle on the otherof the guard 330 and the actuation device 390 for receiving the threadedextension in threaded engagement.

For example, the end 372 of the distal portion 370 of the actuationdevice 390 may be adapted to be insertable into the interior chamber 334of the guard 330 through an opening 333 to attach the guard 330 to theactuation device 390. The distal portion 370 may have a threaded portion376, which may or may not be similar to the threaded portion 276 forengaging the inserting housing 280, for threaded engagement of athreaded portion 336 within the guard 330. The end 372 may be insertableinto the guard 330, for example, until a surface 371, which may or maynot be similar to the surface 271, of the actuation device 390 contactsa portion, such as an outer surface 331 a, of the guard 330 and/or theend 372 contacts a portion, such as an inner surface 331 b, within guard330. In other embodiments, a portion of the guard 330 may be configuredto be insertable into the actuation device 390, for example throughopening 374 through which the lancing portion 350 may be attached to theactuation device 390, to attach the guard 330 to the actuation device390.

In other embodiments, other suitable connection structures may beemployed for connecting the guard 330 with the actuation device 390.Such a connection structure may include, but is not limited to, flexiblepawls or extensions on one or the other of the actuation device 390 andthe guard 330 and a corresponding aperture, stop surface, or the like onthe other of the other of the guard 330 and the actuation device 390.

An aperture 335 or the like may be provided on the housing 332 of theguard 330 and extending through to the interior chamber 334. Theaperture 335 may be located on an end 332 a opposite the opening 333.The aperture 335 may allow the needle 354 or a portion thereof to extendbeyond the end 332 a of the guard 330 to pierce the skin of theuser-patient, for example, when the member 398 is actuated to move thelancing portion 350. In various embodiments, the guard 330 may bearrangeable to adjust the penetration depth of the needle 354. Forexample, by arranging the guard 330 (e.g., screwing on the guard 330)further into or further along the actuation device 390, the penetrationdepth of the needle 354 can be increased accordingly. Conversely, thepenetration depth of the needle 354 can be decreased by arranging guard330 further from the actuation device 390.

As previously discussed, in some embodiments, the actuation device 390may be configured to retract the needle 354 automatically after theneedle 354 pierces the skin of the user-patient. In such embodiments,the needle 354 may pierce or prick the skin of the user-patient and thenreturn to a position (e.g., the third position) within the actuationdevice 390 and/or the guard 330. In other embodiments, the actuationdevice 390 may be configured such that the needle 354 can be manuallyretracted after piercing the skin of the user-patient, for example, byoperating the second trigger 397, or the like.

FIG. 24 illustrates a flowchart for using an actuation device accordingto an embodiment of the present invention. With reference to FIGS.22-24, in step S1202, the lancing portion 350 may be attached to theactuation device 390. In step S1204, the penetration depth of the needle354 may be adjusted.

Next in step S1206, the guard 330 may be attached to the actuationdevice 390. In step S1208, the actuation device 390 may be placedadjacent a suitable injection site on the user-patient. In step S1210,the member 398 and the lancing portion 350 may be actuated to prick theuser-patient at the injection site. In further embodiments, the lancingportion 350 may be removed from the actuation device 390, and theactuation device 390 may be used similar to the actuation device 290 andan infusion set, such as, but not limited to, the system 200 describedwith respect to FIGS. 17-21.

FIGS. 25-29 illustrate an insertion housing 480 according to anembodiment of the present invention. The insertion housing 480 may besimilar to or employed as an embodiment of the insertion housing 280(e.g., FIGS. 17-20), and for example, may be used with the insertingsystem 200 (e.g., FIGS. 17-20) and/or the like discussed in thisdisclosure. Although the insertion housing 480 may be similar or usedwith the embodiments of FIGS. 17-20, it should be understood that theinsertion housing 480 may also include some or all of the samecomponents and operate in a manner similar to that shown and describedin the embodiments of FIGS. 1-16 and 30-43. In addition, some or all ofthe features shown in FIGS. 1-16 and 30-43 may be combined in variousways and included in the embodiments shown in FIGS. 25-29. Likewise, itshould be understood that any of the features of the embodiments ofFIGS. 25-29 may be combined or otherwise incorporated into any of theother embodiments of FIGS. 25-29 as well as any other embodiment hereindiscussed.

With reference to FIGS. 25-29, in some embodiments, the insertionhousing 480 may be used with a first member (e.g., 202 in FIGS. 17-20)having a housing (e.g., 204 in FIGS. 17-20) on a base (e.g., 206 inFIGS. 17-20). The housing 204 may be formed integral with the base 206or may be formed as a separate structure connected to the base 206 in afixed relation to the base 206. The housing 204 and the base 206 eachmay be made of any suitably rigid material, including, but not limitedto plastic, metal, ceramic, composite material, or the like.

The housing may include an injection site section (e.g., 205 in FIGS.17-20) containing an injection site structure in which a hollow needleor cannula may be inserted into a user-patient for conveying fluidicmedia to or from the user-patient. In other embodiments, instead of orin addition to an injection site, the housing 204 may contain, be partof, or be operatively connected to any other suitable structure forconveying, containing, and/or processing fluidic media.

The first member 202 may be operatively connectable to a second member(not shown), which may include a housing (e.g., 108 in FIGS. 7-12),which in the illustrated embodiment may include a reservoir (e.g., 107in FIGS. 7-12) for containing fluidic media. The second member may beheld within or otherwise be covered by an outer housing (e.g., 109 inFIGS. 7-12) configured to attach to the base 206. The outer housing 109may be configured to connect to the base 206 of the first member 202 byany suitable connection structure. In some embodiments, upon couplingthe first member 202 and the second member, fluid flow communication maybe provided between the second member and the injection site section 205in the first member 202.

In particular embodiments, at least one of the outer housing 109 and thebase 206 may include one or more flexible pawls, protrusions,indentations, or the like for engaging and/or receiving one or morecorresponding pawls, protrusions, indentations, or the like on the otherof the base 206 and the outer housing 109 to provide a suitableconnection structure. Alternatively or in addition, the connectionstructure may include adhesive material or other suitable connectors.

The housing 204 may have or be connected to a receptacle structure (e.g.110, 210 in FIGS. 7-12 and 17-20) having a chamber (e.g., 214 in FIGS.17-20). In some embodiments, the receptacle structure 210 may be part ofthe housing adjacent a section of the housing containing the injectionsite section 205. In other embodiments, the receptacle structure 210 mayinclude a further housing connected to the housing.

A fluid conduit (e.g., 224 in FIGS. 17-20), such as, but not limited to,a needle or the like may be supported within the chamber. The fluidconduit 224 may be supported by a supporting structure located withinthe receptacle structure 210. In some embodiments, the supportingstructure may be a wall integral with the receptacle structure 210. Inother embodiments, the supporting structure may be any suitablestructure that is generally fixed relative to the receptacle structure210 and is able to support the fluid conduit 224 in a generally fixedrelation to the receptacle structure 210.

The fluid conduit 224 may be made of any suitably rigid material,including, but not limited to metal, plastic, ceramic, or the like, andmay have a hollow channel extending in a lengthwise dimension of thefluid conduit 224. The hollow channel in the fluid conduit 224 may beopen at a location (not shown) along the lengthwise dimension of thefluid conduit 224, such as, but not limited to, a first end of the fluidconduit 224. The hollow channel in the fluid conduit 224 may be open atanother location (e.g., 224 b in FIGS. 17-20) along the lengthwisedimension of the fluid conduit 224, such as, but not limited to, asecond end of the fluid conduit 224 opposite the first end of the fluidconduit 224. One of the openings in the fluid conduit 224 may beprovided with a septum (e.g., 226 in FIGS. 17-20) that may be pierceableby a needle (not shown), for example as previously described, when areservoir is connected to the first member 202.

The injection site section 205 may include a channel (e.g., 240 in FIGS.17-20) extending through the housing 204 and the base 206. The channel240 may have an open end (e.g., 240 a in FIGS. 17-20) on a bottomsurface (e.g., relative to the orientation shown in FIG. 18) of thebase. The channel 240 may have another open end (e.g., 240 b in FIGS.17-20) at an upper surface (e.g., relative to the orientation shown inFIG. 18) of the injection site section 205 of the housing 204. Thechannel 240 may include a channel section (e.g., 242 in FIGS. 17-20)having a larger radial dimension relative to a remaining portion of thechannel 240 and may have a suitable shape and size to receive an insertstructure, a needle, and/or a cannula, as will be described.

The insertion housing 480 may be made of a material of suitable strengthand durability such as, but not limited to, plastic, metal, glass, orthe like. The insertion housing 480 may be located adjacent the open endof the channel 240 and arranged to selectively extend a needle and/orcannula of an insert structure into the open end of the channel 240 andat least partially through the channel 240, as will be described.

The insertion housing 480 may be a separate device from the housing 204and may be selectively engaged or connected to, for example in alignmentwith the channel 240, and disengaged or disconnected from the injectionsite section 205 and/or the first member 202 or portion thereof. In someembodiments, the insertion housing 480 may be recommended for disposalafter a specified number of uses.

A suitable connection structure, such as that described throughout thisdisclosure, may be provided on the insertion housing 480, the injectionsite section 205, and/or the first member 202 or portion(s) thereof toprovide a manually releasable connection between those components. Forexample, the connection structure may include, but is not limited to, athreaded extension on one or the other of the insertion housing 480 andthe injection site section 205 and a corresponding threaded receptacleon the other of the injection site section 205 and the insertion housing480 for receiving the threaded extension in threaded engagement. Inother embodiments, other suitable connection structures may be employed.These may include, but are not limited to, friction-fitted sections,flexible pawls or extensions on one or the other of the insertionhousing 480 and the injection site section 205 (or the first member 202,or portion thereof) and a corresponding aperture, stop surface, or thelike on the other of the injection site section 205 (or the first member202, or portion thereof) and the insertion housing 480.

In some embodiments, the insertion housing 480 may include one or morelatches 470 configured to operatively engage with and disengage from theinsertion site section 205 (or the first member 202), or the like. Forinstance, in some embodiments, the latch 470 may include an arm 472 withone or more protrusions 474 for engaging with and disengaging from anaperture (e.g., 205 a in FIGS. 17-20), a retaining surface (e.g., 205 bin FIGS. 17-20), and/or the like of the insertion site section 205 (orthe first member), or the like. In some embodiments, the arm 472 mayhave a recess 475, for example defined by the one or more protrusions474 or formed in the arm 472, for engaging a protrusion or the likeprovided on the injection site section 205 (or the first member 202). Inother embodiments, the arm 472 may have one or more apertures (notshown) or the like for receiving one or more protrusions (not shown) orthe like from the insertion site section 205 (or the first member 202),or the like.

The latch 470 may be made of any suitably rigid material, such asplastic, glass, metal, composite material, ceramic, and/or the like. Insome embodiments, the latch 470 may be made of similar material as theinsertion housing 480. In other embodiments, the latch 470 may be madeof different material from the insertion housing 480.

In some embodiments, the latch 470 may be integral with the insertionhousing 480. The latch 470 may be sufficiently flexible to operativelyengage with and disengage from an engagement portion, for example aspreviously described, of the first member 202 as the latch 470 flexestoward and away from the first member.

In other embodiments, the latch 470 may be operatively connected withthe insertion housing 480. For instance, the latch 470 may be adapted topivot about a portion of the insertion housing 480 to allow the latch470 to operatively engage with and disengage from the first member 202as the latch 470 pivots toward and away from the engagement portion ofthe first member 202. For example, the latch 470 may include one or moreapertures for receiving a protrusion 481 a on the insertion housing 480to allow the latch 470 to pivot about the protrusion 481 a. As anotherexample, the latch 470 may include one or more protrusions (not shown)pivotable in one or more apertures (not shown) provided in the insertionhousing 480 to allow the latch 470 to pivot about the apertures in theinsertion housing 480.

Throughout various embodiments in the disclosure, the engagement portionof the first member 202 may be, but is not limited to, an aperture, aridge, an undersurface (or upper surface), a protrusion, a tab, an arm,a bias member, or any other suitable structure or mechanism arrangeableto allow the latch 470 to engage with and/or disengage from the firstmember 202.

In some embodiments, the insertion housing 480 may include a protrusion481 c for engaging an aperture (not shown) or the like in the firstmember 202 to connect the insertion housing 480 to the first member 202.In other embodiments, the insertion housing 480 may include an aperture(not shown) for receiving a protrusion (not shown) or the like in thefirst member 202 to connect the insertion housing 480 to the firstmember 202. In particular embodiments, once the insertion housing 480 isconnected with the first member 202 in any suitable manner, for example(but not limited to) as described above, the latch 480 may be connectedwith the first member 202 to further secure the insertion housing 480 tothe first member 202.

In further embodiments, an abutment 476, such a tab, finger, protrusion,or the like, may be provided on the arm 472 to substantially prevent thelatch 470 from engaging the first member 202 after the latch 470 hasbeen disengaged from the first member 202, for example, as discussed inthe disclosure. Thus, once the latch 470 is disengaged from the firstmember 202, the abutment 476 may prevent the latch 470 from re-engagingthe first member 202, for example, by preventing the latch 470 fromsufficiently pivoting forward.

The insertion housing 480 may contain a main chamber 487 in alignmentwith the opening of the injection site section 205. The insertionhousing 480 may have a longitudinal dimension. An insert structure 460may be located within the insertion housing 480 and moveable along thelongitudinal dimension along a line L. The insert structure 460 may bemoveable at least between a first position and a second position. Theinsert structure 460 may include a first part 462 and a second part 464operatively connected to the first part 462 so that the first part 462and the second part 462 may move together along the line L. The insertstructure 460 may be biased toward or otherwise held in the firstposition until sufficient force is applied to the insert structure 460to move or otherwise actuate the insert structure 460 to the secondposition.

Various examples of suitable structures for insert structures aredescribed in this disclosure, as well as in U.S. patent application Ser.No. 11/645,435, filed Dec. 26, 2006, entitled “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method,” which is assigned to the assignee of the presentinvention and is incorporated herein by reference in its entirety.Further examples of various insert structures are described in, but arenot limited to, U.S. patent application Ser. No. 11/645,972, filed Dec.26, 2006, “Infusion Medium Delivery System, Device And Method WithNeedle Inserter And Needle Inserter Device And Method”; U.S. patentapplication Ser. No. 11/646,052, filed Dec. 26, 2006, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method”; U.S. patent application Ser. No.11/645,435, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; U.S. patent application Ser. No. 11/646,000, filed Dec. 26,2006, “Infusion Medium Delivery System, Device And Method With NeedleInserter And Needle Inserter Device And Method,” all of which are hereinincorporated by reference in its entirety. Other examples of suitablestructures for insert structures are described herein.

The first part 462 of the insert structure 460 may include a plungerhead 488 and a needle 446 supported by the plunger head 488. The secondpart 464 of the insert structure 460 may include a collar 468 and acannula 448 supported by the collar 468. The first part 462 and thesecond part 464 may be configured to be removably attachable from eachother, for example, in a friction fit engagement, snap fit engagement,or the like. For example, one of the plunger head 488 and the collar 468may include protrusions or the like and the other of the plunger head488 and the collar 468 may include apertures for receiving theprotrusions. Accordingly, the first part 462 may be separable from thesecond part 464 upon application of a sufficiently strong separatingforce. In particular embodiments, the plunger head 488 may be connectedto the collar 468.

The cannula 448 may extend at least partially through the collar 468.The cannula 448 may be fixed to the collar 468 to move with movement ofthe insert structure 460. The cannula 448 may have a hollow centralchannel 448 c extending along a longitudinal length of the cannula 448and open at one end 448 a that may be adjacent a sharp end 446 a of theneedle 446 disposed within the cannula 448 as will be discussed. An end448 b of the cannula 448 opposite the open end 448 a may have a head 449having a larger radial dimension than a shaft portion 448 d of thecannula 448.

In some embodiments, the head 449 may be separate from the cannula 448.In such embodiments, the head 449 may be in fluid communication with thecannula 448. For example, a portion of the head 449 may be aligned withthe cannula 448 to allow fluid to flow therebetween. In otherembodiments, the head 449 may be integral with the cannula 448.

A septum 466 may be supported or otherwise retained by the collar 468.The septum 466 may be a resealable member made of silicone, plastic,rubber, Teflon, or the like. The septum 466 may be arranged between theplunger head 488 and the collar 468. The septum 466 may be pierceable bythe needle 446.

The needle 446 may be arranged to extend through at least a portion ofthe cannula 448. The needle 446 may be supported by, secured, and/oroperatively connected to the plunger head 488 to move with movement ofthe insert structure 460. Thus, in some embodiments, the plunger head488 and the needle 446, which may be both part of the first part 462 ofthe insert structure 460, and the collar 468 and the cannula 448, whichmay be both part of the second part 464 of the insert structure 460, maybe moveable at least between the first position and the second position.

In the second position, the needle 446 and the cannula 448 may extendthrough the opening of the channel 240 and at least partially throughthe channel 240. As such, the sharp end 446 a of the needle 446 and atleast a portion of the length of the cannula 448 may extend out theopening of the channel 240, for example, into skin of a user-patient.

The collar 468 of the insert structure 460 may have a suitable shape andsize to fit into the channel section 242 of the channel 240 when theinsert structure 460 is moved to the second position, for example, by anactuation device, as will be discussed. In particular embodiments, thecollar 468 may include one or more protrusions (not shown) and/orindentations that engage with one or more corresponding indentations,such as the aperture, and/or protrusions in the injection site section205 to provide a friction fit, snap fit, or the like. Accordingly, thesecond part 464 may be retained within the injection site section 205upon the insert structure 460 being moved to the second position.

In further embodiments, instead of or in addition to engagingprotrusions and indentations, one or more other mechanical structuresmay be employed to provide a suitable retaining function for retainingthe second part 464 in place within the injection site section 205 uponthe insert structure 460 being moved to the second position, forexample, by an actuation device. These mechanical structures mayinclude, but are not limited to, a friction fit structure, snap fitstructure, or the like.

In various embodiments, the latch 470 of the insertion housing 480 maybe actuated to disengage the insertion housing 480 automatically fromthe first member 202 upon the insert structure 460 being moved to thesecond position. For example, the latch 470 may be adapted to flex orpivot away from the insertion housing 480 to disengage the first member202 when the insert structure 460 is moved to the second position. Inmoving to the second position, a protrusion or the like on the insertstructure 460 may push against the one or more protrusions 474 of thelatch 470 engaged with the first member 202. This may displace the oneor more protrusions 474 of the latch 470 and release the latch 470 fromthe first member 202. Accordingly, in such embodiments, the insertionhousing 480 may be removed.

In some embodiments, removal of the insertion housing 480 may alsoremove the first part 462 (or portion thereof) that may include theneedle 446 and the plunger 488, while leaving the second part 464 (orportion thereof) that may include the cannula 448 and the collar 468engaged to the injection site section 205. In other embodiments, removalof the insertion housing 480 may also remove the first part 462 (orportion thereof), which may include the needle 446 and the plunger 488,and the second part 464 (or portion thereof), which may include thecannula 448 and the collar 468.

The collar 468 may have a connection channel 469 provided in fluid flowcommunication with an opening (not shown) in the cannula 448 in fluidflow communication with the hollow central channel 448 c of the cannula448. In some embodiments, the connection channel 469 may be in fluidflow communication with an opening in the head 449, which may be influid flow communication with the hollow central channel 448 c of thecannula 448. Thus in various embodiments, the connection channel 469 maybe in fluid flow communication with the hollow central channel 448 c ofthe cannula 448.

The connection channel 469 may be provided along the collar 468 at alocation at which the connection channel 469 may align with the fluidconduit 224 upon the insert structure 460 being moved to the secondposition. Thus in some embodiments, in a case where the first member 202and the second member are brought together (e.g., FIG. 9) and the insertstructure 460 is in the second position, a fluid flow path may beestablished between the reservoir in the second member and the cannula448 via the fluid conduit and the connection channel 469.

In some embodiments, the insertion housing 480 may include an innerhousing portion 484 concentrically arranged within an outer housingportion 481. The inner housing portion 484 may have an inner chamber 485in alignment with the chamber 487 in which the insert structure 460 maybe arranged for movement. A lip portion (not shown) or the likeextending from the inner housing portion 484 may be for containing theinsert structure 460 in the inner chamber 485. For example, the insertstructure 460 may be in contact with or otherwise adjacent the lipportion when the insert structure 460 is in the first position.

The outer housing 481 may have an outer chamber 482 between the outerhousing 481 and the inner housing portion 484. The outer chamber 482 maybe for receiving at least a portion of an actuation device for actuatingthe plunger head 488 as will be described. In various embodiments, theinner housing portion 484 may be integral with the outer housing portion481. In other embodiments, the inner housing portion 484 may be separatefrom the outer housing portion 481.

In some embodiments, the inner housing portion 484 may have one orfingers 484 b that extend away from the inner housing portion 484 (in adirection facing an attached actuation device). One or more of thefingers 484 b may include a ridge 484 a for supporting at least aportion of the plunger head 488, for example one or more protrusions 488a or the like of the plunger head 488, prior to movement of the insertstructure 460. The fingers 484 b may be sufficiently rigid, yet flexibleto allow the fingers 484 b and the ridge 484 a to support the insertionstructure 460 and allow the fingers 484 b to be flexed (e.g., toward theouter housing portion 481) or otherwise separated to allow the insertionstructure 460 to move past the ridge 484 a (e.g., the first position).

In particular embodiments, the fingers 484 b and a correspondingactuation device (as will be described) for the insertion housing 480may be configured such that the actuation device sufficiently flexes orotherwise separates the fingers 484 b to allow movement of the insertionstructure 460 beyond the ridge 484 a. Thus, for example, in a case wherethe actuation device is properly connected and the actuation device isactuated, the actuation device may cause the insertion structure 460 tomove from the first position to the second position.

Thus various embodiments may allow for inhibiting a false firing of theinsertion structure 460 unless the actuation device is properlyconnected with the insertion housing 480. In other words, in theseembodiments, even if a force is applied to the insertion structure 460,for example, from an actuation device, the insertion structure 460 willnot be advanced unless the fingers 484 b are flexed or otherwiseseparated (e.g., by properly attaching the actuation device) to providesufficient clearance to allow the insertion structure to advance. Infurther embodiments, the ridge 484 a may have a sloped surface 484 c toallow the insertion structure 460 to move past the ridge 484 a, forexample after the cannula 448 is inserted into the user, to return theinsertion structure 460 to a position in which the insertion structure460 is supported by the ridge 484 a.

As previously discussed, in various embodiments, the insert structure460 (i.e., the plunger head 488, the needle 446, the collar 468, and thecannula 448) may be actuated to move to the second position by (but notlimited to) an actuation device 290 or 390 (e.g., FIGS. 17-24) or otheractuation device discussed in this disclosure. FIGS. 30-43 illustrate anactuation device 500 according to an embodiment of the presentinvention. The actuation device 500 may be similar to or employed as anembodiment of the actuation device 290 or 390 (e.g., FIGS. 17-24), andfor example, may be used with (but not limited to) the inserting system200 (e.g., FIGS. 17-20) and/or the like discussed in this disclosure.

Although the actuation device 500 may be similar or used with theembodiments of FIGS. 17-24, it should be understood that the actuationdevice 500 may also include some or all of the same components andoperate in a manner similar to that shown and described in theembodiments of FIGS. 1-16 and 25-29. In addition, some or all of thefeatures shown in FIGS. 1-16 and 25-29 may be combined in various waysand included in the embodiment shown in FIGS. 30-43. Likewise, it shouldbe understood that any of the features of the embodiments of FIGS. 30-43may be combined or otherwise incorporated into any of the otherembodiments of FIGS. 30-43 as well as any other embodiment hereindiscussed.

With reference to FIGS. 25-43, the actuation device 500 may include ahousing 510, a drive mechanism 560, and a drive member 540. The housing510 may be securable to the insertion housing 480 or any other insertionhousing, for example (but not limited to) as described in thisdisclosure. The housing 510 may be made of any suitably rigid material,including, but not limited to plastic, metal, ceramic, glass, compositematerial, and/or the like. A suitable connection structure may beprovided on the actuation device 500 and/or the insertion housing 480,for example as described in this disclosure, to provide a manuallyreleasable connection between those components. In some embodiments, theconnection structure may include, but is not limited to, a threadedextension on one or the other of the actuation device 500 and theinsertion housing 480 and a corresponding threaded receptacle on theother of the insertion housing 480 and the actuation device 500 forreceiving the threaded extension in threaded engagement.

In some embodiments, a distal portion 530 of the actuation device 500may be adapted to engage the insertion housing 480. The distal portion530 may have an inner chamber 536 for receiving at least a portion ofthe insertion housing 480. The distal portion 530 may be integral withthe housing 510. In other embodiments, the distal portion 530 may beseparate and connected with the connected with the housing 510. Thedistal portion 530 may be made of any suitably rigid material,including, but not limited to plastic, metal, ceramic, glass, compositematerial, and/or the like.

The distal portion 530 may have least one slot 532 or the like forengaging at least one tab 481 e or the like of the insertion housing480, which may be located on an outer periphery of the outer housingportion 481. For example, the slot 532 may receive the tab 481 e as theactuation device 500 is connected with the insertion housing 480.

In further embodiments, the distal portion 530 and/or the insertionhousing 580 may be configured so that an additional rotation of theactuation device 500 relative to the insertion housing 480 may lock thetab 481 e in the slot 532. In yet further embodiments, the additionalrotation of the actuation device 500 relative to the insertion housing480 may cause the legs 484 b to separate to allow the insertionstructure 460 to be moved by the actuation device 500 as described. Forexample, the distal portion 530 may have an edge 537, surface, tab, orthe like within the chamber 536 for forcing the legs 484 b apart, forexample, in a case where the actuation device 500 receives a portion ofthe insertion housing 480 and the actuation device 500 is rotatedrelative to the insertion housing 480. In other embodiments, theinsertion housing 480 may include at least one slot (not shown) forreceiving at least one tab (not shown) of the actuation device 500. Inother embodiments, the distal portion 530 of the actuation device 500may be adapted to be insertable into the insertion housing 480, forexample, within the outer chamber 482.

Thus in various embodiments, the insertion housing 480 and/or theactuation device 500 may be configured to lock the actuation device 500to the insertion housing 480, for example, in a case where the tab 481 eis received in the slot 532 and the actuation device 500 is rotatedrelative to the insertion housing 480. The actuation device 500 may beunlocked from the insertion housing 480, for example, by rotating theactuation device 500 relative to the insertion housing 480 in anopposite direction from the direction for locking the two components.

In other embodiments, other suitable connection structures may beemployed. Such a connection structure may include, but is not limitedto, friction-fitted sections of the insertion housing 480 and theactuation device 500, flexible pawls or extensions on one or the otherof the actuation device 500 and the insertion housing 480 and acorresponding aperture, stop surface, or the like on the other of theinsertion housing 480 and the actuation device 500.

The housing 510 may include an outer body 512 and an inner body 514concentrically arranged within the outer body 512. The outer body 512and the inner body 514 may define an outer chamber 513. The inner body514 may have an inner chamber 515. The inner chamber 515 may be incommunication with the inner chamber 536 of the distal portion 530 ofthe actuation device 500. A cam assembly 580 may be supported in theouter chamber 513 between the outer body 512 and the inner body 514.

The drive member 540 may be supported in the inner chamber 515 of theinner body 514 and moveable along a longitudinal dimension of theactuation device 500 through at least a portion of the inner chamber 515and the inner chamber 536 at least between a first position and a secondposition. The inner body 514 may have a groove 514 a extending at leasta portion of the inner body 514 to allow movement of a portion (e.g.,protrusion 544) of the drive member 540.

The drive member 540 may be made of any suitably rigid material,including, but not limited to plastic, metal, ceramic, glass, compositematerial, and/or the like. The drive member 540 may be moveable along aline M at least between a first position and a second position. The lineM traveled by the drive member 540 and line L traveled by the insertstructure 460 may share a common axis, for example, in a case where theactuation device 500 and the insertion housing 480 are connectedproperly.

In various embodiments, the drive member 540 may be adapted tooperatively engage the plunger head 488, for example, when the actuationdevice 500 is connected to the insertion housing 480, in any suitablemanner discussed in this disclosure. In some embodiments, the drivemember 540 may include a magnet 548 or the like for interacting with amagnet or magnetically attractive element 490 (e.g., metal, ferrousconduit, and/or the like) operatively connected with the plunger head488 to allow the drive member 540 to operatively engage the insertstructure 460.

In other embodiments, the drive member 540 may include a magneticallyattractive element (not shown) (e.g., metal, ferrous conduit, and/or thelike) for interacting with a magnet (not shown) operatively connectedwith the plunger head 488 to allow the drive member 540 to operativelyengage the insert structure 460. Such embodiments including a magnet inat least one of the insertion housing 480 and the actuation device 500may allow for operatively engaging the actuation device 500 and theinsertion housing 480. In addition, such embodiments may allow forimproved alignment of the actuation device 500 with the insertionhousing 480 when the two components are being connected.

Thus in various embodiments, in a case where the drive member 540 isoperatively engaged with the plunger head 488 and the drive member 540is actuated, the insert structure 460, which may include the plungerhead 488, the needle 446, the collar 468, and the cannula 448, may bemoved to the second position. Thus movement of the drive member 540along the line M from the first position to the second position maycause the insert structure 460 to move from the first position to thesecond position.

Similarly as previously described, the drive member 540 can be furtheractuated to move the first part 462 of the insert structure 460, whichmay include the plunger head 488 and the needle 446, away from thesecond position (e.g., to (or toward) the first position and/or a thirdposition). Thus, the second part 464 of the insert structure 460, whichmay include the collar 468 and the cannula 448, may remain in the secondposition to allow fluid to flow from the reservoir though the fluidconduit and the connection channel 469 to the cannula 448 into theuser-patient as previously described. As such, the needle 446 may beremoved from the user-patient while retaining the cannula 448 in theuser-patient. In particular embodiments that include a magnet (e.g.,magnet 548) in at least one of the insertion housing 480 and theactuation device 500, an attractive force between the magnet and anattractive element (e.g., another magnet, metal, ferrous conduit, and/orthe like) may allow for retraction of the needle 446 from theuser-patient in a case where the drive member 540 is moved away from theinsertion housing 480 (e.g., toward the first position).

The drive mechanism 560 may be for actuating the drive member 540. Thedrive mechanism 560, which may include or may be a bias member 564, suchas, but not limited to, a coil spring, or the like, arranged within theactuation device 500. The bias member 564 may be configured to impart aforce on the drive member 540 to urge the drive member 540 at least fromthe first position toward the second position.

In various some embodiments, the drive mechanism 560 may be employed tomove the drive member 540 at least between the first position and thesecond position. The drive mechanism 560 may be any suitable mechanism,for example (but not limited to) as described in this disclosure, forproviding a driving force to the drive member 540 to move the drivemember 540 at least between the first position and the second position.

In various embodiments, the drive mechanism may include an activationmechanism, such as the knob 520, trigger, button, or the like, forcontrolling the actuation device 500. For instance, the knob 520 may beconfigured to arm, prime, or otherwise prepare the actuation device 500for moving the drive member 540 to move the insert structure 460. Assuch, the knob 520 may be for adjusting or otherwise setting the drivingforce (e.g., priming) for moving the drive member 540 at least betweenthe first position and the second position.

In particular embodiments, the knob 520 may be operatively engaged withthe cam assembly 580, as will be described, so that movement (e.g.,rotation) of the knob 520 causes movement (e.g., rotation) of the camassembly 580. In such embodiments, the knob 520 may be for priming theactuation device 500 for firing.

In some embodiments, the bias member 564 may be a torsion spring 564 orthe like. The drive mechanism 560 may include a retainer member 562. Theknob 520 may be operatively engageable with the retainer member 562. Forexample, the knob 520 may include teeth (not shown) or the like formating with teeth 562 a of the retainer member 562. As such, the knob520 and the retainer member 562 may engage each other so that theretainer member 562 can be moved with movement of the knob 520, forexample, in a clockwise or counter-clockwise direction. In someembodiments, the torsion spring 564 may be provided around the retainermember 562 (or any other suitable location).

In various embodiments, the torsion spring 564 and the knob 520 may beoperatively connected with the cam assembly 580 such that movement ofthe knob 520 (in one or more directions) winds or otherwise primes thetorsion spring 564. For instance, the torsion spring 564 may have an end564 a for fitting into an aperture or the like (not shown) in the camassembly 580 and the knob 520 may be operatively engaged with the camassembly 580, for example as described in this disclosure. As such,rotation of the cam assembly 580, for example by winding the knob 520,may wind the torsion spring 564 to prime the torsion spring 564. Thus invarious embodiments, the knob 520 may be configured to selectively armthe actuation device 500.

In various embodiments, the torsion spring 564 may be operativelyconnected with the cam assembly 580 to allow the torsion spring 564 toapply a force on the cam assembly 580, for example, in a case where thetorsion spring 564 has been primed (e.g., by winding the knob 520sufficiently in a first direction) and energy stored by the torsionspring 564 (from priming the torsion spring 564) is released (or thetorsion spring 564 is otherwise allowed to move the cam assembly 580 ina second direction, opposite the first direction), for example, byactuating a trigger or the like as will be described. Thus, theactuation device 590 (e.g., the drive member 540) may be fired bypriming the torsion spring 564, and releasing the energy stored by thetorsion spring 564 to apply a force on the cam assembly 580 to cause thecam assembly 580 to drive or otherwise move the drive member 540 atleast between the first position and the second position.

In some embodiments, a bias member, such as a spring 566, or the likemay be operatively engaged with the drive mechanism 560 to provide abias force to the drive mechanism 560, for example, to prevent the knob520 from rotating in a direction opposite (e.g., the second direction) adirection (e.g., the first direction) for priming the drive mechanism560. In some embodiments, the knob 520 and/or the retainer member 562may be configured to act as a ratchet or the like. Such embodiments mayallow the user-patient to apply multiple partial rotations to the knob520 to arm the actuation device 500 as opposed to having to rotate theknob completely in a single attempt to arm the actuation device 500. Forexample, the teeth of the knob 520 may engage with the teeth 562 a ofthe retaining member 562 as the knob is rotated 520 to allow continuedmovement of the knob 520 in one direction (e.g., the first direction)while preventing the knob from 520 moving in the opposite direction(e.g., the second direction).

The knob 520 and/or the retainer 562 may be secured or otherwiseoperatively connected to the housing 510 in any suitable mannerincluding, but not limited to, screws, bolts, fasteners, and/or thelike. In particular embodiments, a self-tapping screw 570 (or the like)may be employed in a bore 563 of the retainer member to fasten the knob520 and/or the retainer 562 to the housing 510. In further embodiments,a washer 568 or the like may be provided with the self-tapping screw (orother fastener).

The cam assembly 580 may comprise a drum cam 582 and a drum cam top 590.Each of the drum cam 582 and the drum cam top 590 may be made of anysuitably rigid material, including, but not limited to plastic, metal,ceramic, glass, composite material, and/or the like. The drum cam 582may have an interior 585 in which the drum cam top 590 may be supported.For example, the drum cam 582 may have a ridge 582 a upon which at leasta portion of the drum cam top 590 may sit. The drum cam 582 may includeone or more tabs 582 b that fit into corresponding apertures 590 a inthe drum cam top 590. The tabs 582 b may prevent the drum cam top 590from rotating (relative to the drum cam 582) in the interior 585 of thedrum cam 582. Thus the drum cam top 590 may move (e.g., rotate) withmovement (e.g., rotation) of the drum cam 582, for example, relative tothe housing 510 and the drive member 540. In other embodiments, the drumcam 582 may include apertures (not shown) for receiving correspondingtabs (not shown) of the drum cam top 590.

The drum cam 582 may have a first interior surface 587 and a secondinterior surface 586 that is raised relative to the first interiorsurface 587. A sloped surface 586 a may define a perimeter of the secondinterior surface 586. The second interior surface 586 may be relativelyflush with an interior surface 596 of the drum cam top 590 in a casewhere the drum cam top 590 is supported in the interior 585 of drum cam582. A sloped surface 596 a may define a perimeter of the interiorsurface 596 of the drum cam top 590. The interior surface 596 of thedrum cam top 590 and a sloped surface 596 a may define an interior 595.

The sloped surface 596 a of the drum cam top 590 and the sloped surface586 a of the drum cam 582 may define a track 588, groove, or the likebetween the two components. The drive member 540 may have a protrusion544 or the like arranged for movement in the track 588. The protrusion544 may be guided or otherwise moved by the cam assembly 580 along thetrack 588 to move the drive member 540 at least between the firstposition and the second position. For instance, the sloped surface 596 aof the drum cam top 590 and the sloped surface 586 a of the drum cam 582may provide a circular track that spirals along the cam assembly 580 toallow the cam assembly 580 to rotate relative to the drive member 540.As such, rotation of the cam assembly 580 may guide the protrusion 544along the track 588 to cause movement of the drive member 540 at leastbetween the first position and the second position.

Thus in some embodiments, a cam assembly with a track along which aprotrusion (or other portion) of a drive member is guided may beassembled using two separate components. Such embodiments may allow forcheaper and easier manufacturing (e.g., molding) processes. In otherembodiments, the cam assembly 580 may be formed as one component withthe track 588 formed therein. In yet other embodiments, the cam assemblymay be assembled using any number of suitable components.

As mentioned, in some embodiments, the protrusion 544 of the drivemember 540 may be arranged in the track 588 of the cam assembly 580. Insuch embodiments, when the actuation device 500 is fired, for examplewhen the torsion spring 564 is released, the cam assembly 580 may rotate(e.g., in the second direction) relative to the drive member 540. As aresult, a portion of the cam assembly (e.g., the sloped surface 596 a ofthe drum cam top 590) may push or otherwise guide the protrusion 544 ofthe drive member 540 along the track 588. Thus, as the cam assembly 580rotates, the drive member 540, via the cam assembly 580 pushing on theprotrusion 544, may be moved between the first position and the secondposition.

In further embodiments, when the actuation device 500 is primed, forexample when the knob 520 is wound, the cam assembly 580 may be rotated(e.g., in the first direction) relative to the drive member 540. As aresult, a portion of the cam assembly (e.g., the sloped surface of thedrum cam 582) may push or otherwise guide the protrusion 544 of thedrive member 540 along the track 588. Thus, as the cam assembly 580rotates, the drive member 540, via the cam assembly 580 pushing on theprotrusion 544, may be moved between the second position and the firstposition.

In some embodiments, the cam assembly 580 may be configured tocompensate or otherwise provide a tolerance for the protrusion 544 ofthe drive member 540 (relative to the cam assembly 580) as theprotrusion 544 is guided along the track 588 by the cam assembly 580 tomove the drive member 540 between the first position and the secondposition.

In particular embodiments, the cam assembly 580 may include a cap 592and a bias member, such as a spring 594 or the like. The cap 592 may besupported on the drum cam 582. The drum cam top 590 may be supportedwithin the drum cam 582 such that the drum cam top 590 may slide orotherwise move within the interior 585 of the drum cam 582, for example,toward and away from the cap 592 (e.g., along the line M). The spring594 may be arranged between the drum cam top 590 and the cap 592 toprovide a bias force on the drum cam top 590. For instance, the spring594 may provide a bias force in a direction away from the cap 592, forexample, when the actuation device 500 is fired so that the cam assembly580 is rotated (e.g., in the second direction) causing the drum cam top590 to push or otherwise guide the protrusion 544 to move the drivemember 540 from the first position to the second position.

As such, the spring 594 may compensate for any shifting or othervariation between the drum cam top 590 and the drum cam 582 caused bythe cam top 590 guiding the protrusion 544 toward the bottom of thetrack 588 (e.g., position B in FIG. 35). For instance, the spring 594may cause continued movement of the protrusion 544 until reaching thebottom of the track 588. Such embodiments may allow for compensating anyvariation in distance between, for example, the sloped surface 596 ofthe drum cam top 590 and the sloped surface 586 a of the drum cam 582.Thus, any variation can be compensated before the protrusion 544 guidedup the track 588 (e.g., toward position A in FIG. 35), for example toprime the actuation device 500 again (or for the first time). This mayensure that the drive member 540 and/or the insert structure 560 hastraveled an expected distance, for example, a distance required tosufficiently insert the cannula 448 into the user-patient.

In addition, in various embodiments, the spring 594 may provide a biasforce in a direction away from the cap 592, for example, when theactuation device 500 is primed so that the cam assembly 580 is rotated(e.g., in the first direction) causing the drum cam 582 to push orotherwise guide the protrusion 544 to move the drive member 540 from thesecond position to the first position (or other position). As such, thespring 594 may compensate for any shifting or other variation betweenthe drum cam top 590 and the drum cam 582 caused by the drum cam 582guiding the protrusion 544 toward the top of the track 588 (e.g.,position A in FIG. 35). For instance, the spring 594 may cause continuedmovement of the protrusion 544 until reaching the top of the track 588.Such embodiments may allow for compensating any variation in distancebetween, for example, the sloped surface 596 of the drum cam top 590 andthe sloped surface 586 a of the drum cam 582. Thus, any variation can becompensated before the protrusion 544 guided down the track 588 (e.g.,toward position B in FIG. 35), for example to fire the actuation device500 again (or for the first time). This may ensure that the drive member540 and/or the insert structure 560 has traveled an expected distance,for example, a distance required to sufficiently prime the actuationdevice 500 or component thereof.

In particular embodiments, the drum cam 582 and the cap 592 may be keyedto fit with each other. For instance, the drum cam 582 may have a tab582 b, protrusion or the like that fits into a recess 592 b in the cap592. In other embodiments, the drum cam 582 may have a recess (notshown) for receiving a tab (not shown), protrusion, or the like of thecap 592. In other embodiments, the cap 592 may be fit with the camassembly 580 in any suitable manner such as (but not limited to) afriction fitting, welding, adhesive fitting, and/or the like. In someembodiments, the cap 592 may be a separate component from the drum cam582. In other embodiments, the cap 592 may be integral with the drum cam582. The cap 592 may be made of any suitably rigid material, including,but not limited to plastic, metal, ceramic, glass, composite material,and/or the like.

A trigger 554 or the like may be configured to selectively fire orotherwise actuate the actuation device 500, for example after the knob520 has sufficiently primed the actuation device 500. For instance, thetrigger 554 may be operatively connected to the bias member 564 to allowa force of the bias member to drive the drive member 540, for example byrotating the cam assembly 580, to the second position upon activation ofthe trigger 554.

In some embodiments, the trigger 554 may be configured to lock orotherwise prevent movement of at least one of the drive member 540, thecam assembly 580, and the bias member 564 in a particular direction ororientation until the trigger 554 is released or otherwise activated.For example, the trigger 554 may include a catch 555 for engaging withand disengaging from a portion of the drum cam 582, such as an abutment583 a of the drum cam 582. As such, rotation of the drum cam 582, forexample in the second direction, may be substantially prevented in acase where, for example, the actuation device 500 is armed (e.g., bysufficiently winding the knob 520) and the abutment 583 a of the drumcam 582 is engaged by the catch 555.

The trigger 554 may be mounted in the housing 510 and/or the distalportion 530. For example, the trigger 554 may have one or more of afirst protrusion 554 a and a second protrusion 554 b for fitting intoone or more of an aperture 510 a in the housing 510 and an aperture 530a in the distal portion 530, respectively. Accordingly, the trigger 554may be pivotable about the first protrusion 554 a and the secondprotrusion 554 b. For instance, the trigger 554 may be pressed (orotherwise activated) to pivot the trigger 554 to provide sufficientclearance between the catch 555 and the abutment 583 a of the drum cam582 to disengage the catch 555 from the abutment 583 a. In otherembodiments, the trigger 554 may have one or more of a first aperture(not shown) and a second aperture (not shown) for receiving one or moreof a protrusion (not shown) of the housing 510 and/or a protrusion (notshown) of the distal portion 530, respectively

In a case where the actuation device 500 is not primed (or in a casewhere the actuation device 500 has been fired), the catch 555 may restagainst an abutment 583 b of the drum cam 582. As the actuation device500 is armed, for example, by winding the knob 520, the drum cam 582 maybe rotated (e.g., in the first direction) relative to the housing 510and the trigger 554 to allow the catch 555 to travel relative to thedrum cam 582 along a groove 583 having a first end defined by theabutment 583 b and a second end defined by the abutment 583 a. The catch555 may be allowed to travel in the same direction relative to the drumcam 582 until the catch 555 engages the abutment 583 a on the other endof the groove 583, which may indicate that the actuation device 500 hasbeen sufficiently armed. As described, as the cam assembly 580 isrotated (e.g., in the first direction), a portion of the cam assembly580 (e.g., the sloped surface 586 a of the drum cam 582) pushes orotherwise guides the protrusion 544 along the track 588. Thus, as thecam assembly 580 rotates, the drive member 540, via the cam assembly 580pushing on the protrusion 544, may be moved between the second positionand the first position to prime the actuation device 500.

In some embodiments, in a case where the protrusion 544 is guided alongthe track 588 to move the drive member 540 between the second positionand the first position, the protrusion 544 may be guided in a direction(e.g., the first direction) opposite a direction (e.g., the seconddirection) in which the protrusion 544 travels along the track 588 asthe drive member 540 is moved between the first position and the secondposition. In other embodiments, in a case where the protrusion 544 isguided along the track 588 to move the drive member 540 between thesecond position and the first position, the protrusion 544 may travel ina same direction (e.g., continued relative movement along the track 588)in which the protrusion 544 is guided along the track 588 as the drivemember 540 is moved between the first position and the second position.In such embodiments, for example, the track 588 may be a circular trackwithin the cam assembly 580. In further embodiments, the circular track588 may be “V”-shaped (e.g., FIGS. 32 and 40) or otherwise have a“V”-shaped cross-section.

In some embodiments, a safety mechanism 550 may be provided forpreventing the trigger 554 from being releasable or otherwise activatedunless the actuation device 500 is sufficiently armed (e.g., by windingthe knob 520 sufficiently). For example, the safety mechanism 550 mayinclude a bar 552 supported within the housing 510 and adjacent the drumcam 582. A first end of the bar 552 located near the drum cap 592 mayhave an angled surface 552 a and a second end, opposite the first end,may include a shelf 552 b. The bar 552 may be arranged for movementbetween a first position and a second position as the drum cam 582 isrotated. In a case where the bar 552 is in the first position, the shelf552 b may obstruct or otherwise prevent the trigger 554 from beingpressed to release the catch 555 to allow the drum cam 582 to rotate,thus firing the actuation device 500. In a case where the bar 552 is inthe second position, the trigger 554 may be free of the shelf 552 b,thus allowing the trigger 552 to be activated to allow the drum cam 582to rotate to fire the actuation device 500.

A bias member, such as a spring 556 or the like, may be arranged in theactuation device 500, for example (but not limited to) in an aperture531 a in the distal portion 530, to provide a bias force on the bar 552toward the first position (i.e., a position in which the trigger 554cannot be pressed or otherwise activated because of obstruction by theshelf 552 b of the bar 552).

The bar 552 may be operatively engaged with the knob 520 so thatrotation of the knob 520 may cause movement of the bar 552 at leastbetween the first position and the second position. For instance, theknob 520 may include a surface 523, edge, protrusion (or the like) forengaging a protrusion 592 c (or the like) of the cap 592 so thatrotation of the knob 520 (e.g., in the first direction) to prime theactuation device 500 may cause the cap 592 and the connected drum cam582 to rotate as previously described. The surface 523 of the knob 520may continue to move the protrusion 592 c to rotate the cap 592 and theconnected drum cam 582 to allow the surface 523 of the cap 592 to movealong the angled surface 552 a of the bar 552. Continued movement of thesurface 523 of the cap 592 over the bar 552 may cause the bar 552 tomove to the second position to free the trigger 554 from the shelf 552 bof the bar 552. Accordingly, the trigger 554 may be free to be pressedor otherwise activated to actuate the actuation device 500.

In other embodiments, the knob 520 may be configured to selectivelyrelease the drive member 540 and/or the bias member 564 to allow thedrive member 540 to move along the line M at least between the firstposition and the second position under the force of the bias member 564to the second position upon being operated after the actuation device500 is armed. For example, operating the knob 520 a first time mayretract the drive member 540 to the first position and/or arm the biasmember 564, and further operating the knob 520 a second time may releaseor otherwise allow the drive member 540 to advance to the secondposition. Other examples of insertion structures are described in, butare not limited to, U.S. Pat. Pub. No. US 2007/0142776, entitled“Insertion Device for an Insertion Set and Method of Using the Same,”which is herein incorporated by reference in its entirety.

In various embodiments, the actuation device 500 may be configured forimproved handling of the actuation device 500 by the user-patient. Forexample, the actuation device 500 may include a handling portion 528,grips, textured surfaces, or the like that may aid in handling of theactuation device 500. In some embodiments, the handling portion 528 maybe arranged on the knob 520, the housing 510, and/or any other locationon the actuation device 500 on which improved handling may be desired.

The embodiments disclosed herein are to be considered in all respects asillustrative, and not restrictive of the invention. The presentinvention is in no way limited to the embodiments described above.Various modifications and changes may be made to the embodiments withoutdeparting from the spirit and scope of the invention. The scope of theinvention is indicated by the attached claims, rather than theembodiments. Various modifications and changes that come within themeaning and range of equivalency of the claims are intended to be withinthe scope of the invention.

What is claimed is:
 1. An actuation device, comprising: a housing havinga distal end portion; a lancing device configured to be held by andmoveable relative to the distal end portion of the housing, the lancingdevice having a piercing member; a drive member supported by the housingand moveable in a first direction, the drive member arranged tooperatively engage the lancing device when the lancing device is held bythe distal end portion of the housing, to move the lancing device in thefirst direction from a retracted position to an extended position uponmovement of the drive member in the first direction, the retractedposition of the lancing device relative to the distal end portion of thehousing being adjustable; a drive mechanism supported by the housing toimpart a bias force on the drive member to urge the drive member in thefirst direction; wherein the piercing member of the lancing device isarranged to extend from the distal end portion of the housing by a firstdistance when the lancing device is moved to the extended position, thefirst distance being adjustable by adjusting the retracted position ofthe lancing device relative to the distal end portion of the housing. 2.The actuation device of claim 1, wherein the lancing device isconfigured to be selectively detached from the housing, and wherein thehousing includes a connection mechanism for selectively connecting thedistal end portion of the housing to an insertion device having amoveable needle and cannula when the lancing device is detached from thehousing.
 3. The actuation device of claim 2, wherein the drive member isarranged to selectively engage and move the moveable needle of theinsertion device when the distal end of the housing is connected to theinsertion device housing.
 4. The actuation device of claim 2, furthercomprising a cover configured to be selectively attached to theconnection mechanism on the housing when the lancing device is held bythe distal end portion of the housing.
 5. The actuation device of claim4, wherein the connection mechanism comprises a threaded section of thedistal end portion of the housing configured for engaging a threadedportion of the cover.
 6. The actuation device of claim 5, wherein thethreaded section of the distal end portion of the housing is configuredfor threaded engagement with a threaded portion of the insertion devicehousing when the lancing device is detached from the housing.
 7. Theactuation device of claim 4, wherein the cover includes an aperturethrough which a portion of the piercing member extends, when the lancingdevice is held by the distal end portion of the housing and is in theextended position.
 8. The actuation device of claim 4, wherein the coverincludes an aperture through which a length portion of the piercingmember extends, when the lancing device is held by the distal endportion of the housing and is in the extended position, wherein thelength portion of the piercing member that extends through the apertureis adjustable by adjusting the position of the cover relative to thedistal end portion of the housing.
 9. The actuation device of claim 8,wherein the connection mechanism comprises a threaded section of thedistal end portion of the housing configured for threaded engagementwith a threaded portion of the cover and adjusting the position of thecover relative to the distal end portion of the housing by adjusting thethreaded engagement.
 10. The actuation device of claim 1, wherein thepiercing member comprises a needle.
 11. An actuation device, comprising:a housing having a distal end portion; a lancing device configured to beheld by and moveable relative to the distal end portion of the housing,the lancing device having a piercing member, the lancing device beingconfigured to be selectively detached from the housing, a connectionmechanism for selectively connecting the distal end portion of thehousing to an insertion device having a moveable needle and cannula whenthe lancing device is detached from the housing; a drive membersupported by the housing and moveable in a first direction; and a drivemechanism supported by the housing to impart a bias force on the drivemember to urge the drive member in the first direction; wherein thedrive member is arranged to operatively engage the lancing device whenthe lancing device is held by the distal end portion of the housing, tomove the lancing device in the first direction from a retracted positionto an extended position upon movement of the drive member in the firstdirection; and wherein the drive member is arranged to operativelyengage and move the moveable needle of the insertion device when thelancing device is detached and the distal end of the housing isconnected to the insertion device housing.
 12. The actuation device ofclaim 11, wherein the retracted position of the lancing device relativeto the distal end portion of the housing is adjustable, and wherein thepiercing member of the lancing device is arranged to extend from thedistal end portion of the housing by a first distance when the lancingdevice is moved to the extended position, the first distance beingadjustable by adjusting the retracted position of the lancing devicerelative to the distal end portion of the housing.
 13. The actuationdevice of claim 11, further comprising a cover configured to beselectively attached to the connection mechanism on the housing when thelancing device is held by the distal end portion of the housing.
 14. Theactuation device of claim 13, wherein the connection mechanism comprisesa threaded section of the distal end portion of the housing configuredfor engaging a threaded portion of the cover.
 15. The actuation deviceof claim 14, wherein the threaded section of the distal end portion ofthe housing is configured for threaded engagement with a threadedportion of the insertion device housing when the lancing device isdetached from the housing.
 16. The actuation device of claim 13, whereinthe cover includes an aperture through which a portion of the piercingmember extends, when the lancing device is held by the distal endportion of the housing and is in the extended position.
 17. Theactuation device of claim 13, wherein the cover includes an aperturethrough which a length portion of the piercing member extends, when thelancing device is held by the distal end portion of the housing and isin the extended position, wherein the length portion of the piercingmember that extends through the aperture is adjustable by adjusting theposition of the cover relative to the distal end portion of the housing.18. The actuation device of claim 17, wherein the connection mechanismcomprises a threaded section of the distal end portion of the housingconfigured for threaded engagement with a threaded portion of the coverand adjusting the position of the cover relative to the distal endportion of the housing by adjusting the threaded engagement.
 19. Theactuation device of claim 11, wherein the piercing member comprises aneedle.
 20. A method of making an actuation device, comprising:providing a housing having a distal end portion; holding a lancingdevice with the housing, for movement relative to the distal end portionof the housing, the lancing device having a piercing member; supportinga drive member by the housing, for movement in a first direction, andarranging the drive member to operatively engage the lancing device whenthe lancing device is held by the distal end portion of the housing, tomove the lancing device in the first direction from a retracted positionto an extended position upon movement of the drive member in the firstdirection, wherein the retracted position of the lancing device relativeto the distal end portion of the housing is adjustable; supporting adrive mechanism by the housing to impart a bias force on the drivemember to urge the drive member in the first direction; arranging thepiercing member of the lancing device to extend from the distal endportion of the housing by a first distance when the lancing device ismoved to the extended position; and adjusting the first distance byadjusting the retracted position of the lancing device relative to thedistal end portion of the housing.